Dose-Finding Trial With Sugammadex Administered at 3 and... | NCT00535743 | Trialant
NCT00535743
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 11, 2019Actual
Enrollment
174Actual
Phase
Phase 2
Conditions
Anesthesia, General
Interventions
Sugammadex
Placebo
Esmeron®
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00535743
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P05944
Secondary IDs
ID
Type
Description
Link
19.4.206
Other Identifier
Organon Protocol Number
MK-8616-024
Other Identifier
Merck Protocol Number
Brief Title
Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
Official Title
A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 4, 2004Actual
Primary Completion Date
Jul 20, 2004Actual
Completion Date
Jul 20, 2004Actual
First Submitted Date
Sep 25, 2007
First Submission Date that Met QC Criteria
Sep 25, 2007
First Posted Date
Sep 26, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 6, 2018
Results First Submitted that Met QC Criteria
Sep 6, 2018
Results First Posted Date
Feb 11, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 6, 2018
Last Update Posted Date
Feb 11, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Detailed Description
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.
Conditions Module
Conditions
Anesthesia, General
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
174Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A. Placebo; 3 min after 1 mg/kg Esmeron®
Placebo Comparator
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Placebo
Drug: Esmeron®
Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sugammadex
Drug
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Up to 240 minutes following administration of study treatment
Secondary Outcomes
Measure
Description
Time Frame
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants of ASA class 1 - 3, above or equal to the age of 18 years;
Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
Participants scheduled for surgical procedures in supine position;
Participants who had given written informed consent.
Exclusion Criteria:
Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
Participants who had already participated in this trial;
Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;
Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
N=2 participants (randomized to Arm O) received (rec'd) 8 mg/kg Sugammadex, 3 minutes (min) after 1.2 mg/kg Esmeron® and are counted as Started/Treated in Arm P. Further, N=1 participant (randomized to Arm Q) rec'd 12 mg/kg Sugammadex, 29 min after 1.2 mg/kg Esmeron® and is counted as Started/Treated in Arm W.
Recruitment Details
Of the N=174 randomized participants, N=173 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
FG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Denmark
Germany
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Sugammadex
Drug: Esmeron®
Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm G. Placebo; 15 min after 1 mg/kg Esmeron®
Placebo Comparator
Placebo (single intravenous (IV) bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Placebo
Drug: Esmeron®
Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Experimental
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®
Placebo Comparator
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Placebo
Drug: Esmeron®
Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®
Placebo Comparator
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Placebo
Drug: Esmeron®
Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Experimental
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Drug: Sugammadex
Drug: Esmeron®
Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Org 25969
MK-8616
BRIDION®
Placebo
Drug
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
Arm A. Placebo; 3 min after 1 mg/kg Esmeron®
Arm G. Placebo; 15 min after 1 mg/kg Esmeron®
Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®
Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®
NaCl 0.9%
Esmeron®
Drug
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Arm A. Placebo; 3 min after 1 mg/kg Esmeron®
Arm B. 2 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm C. 4 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm D. 8 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm E. 12 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm F. 16 mg/kg sugammadex; 3 min after 1 mg/kg Esmeron®
Arm G. Placebo; 15 min after 1 mg/kg Esmeron®
Arm H. 2 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm I. 4 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm J. 8 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm K. 12 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm L. 16 mg/kg sugammadex; 15 min after 1 mg/kg Esmeron®
Arm M. Placebo; 3 min after 1.2 mg/kg Esmeron®
Arm N. 2 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm O. 4 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm P. 8 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm Q. 12 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm R. 16 mg/kg sugammadex; 3 min after 1.2 mg/kg Esmeron®
Arm S. Placebo; 15 min after 1.2 mg/kg Esmeron®
Arm T. 2 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm U. 4 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm V. 8 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm W. 12 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Arm X. 16 mg/kg sugammadex; 15 min after 1.2 mg/kg Esmeron®
Zemuron®
Rocuronium bromide
Up to 200 minutes following administration of study treatment
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Up to 180 minutes following administration of study treatment
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Up to 7 days following administration of study treatment
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
FG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
FG0005 subjects
FG00111 subjects
FG00211 subjects
FG00311 subjects
FG00411 subjects
FG00510 subjects
FG0063 subjects
FG0075 subjects
FG0085 subjects
FG0095 subjects
FG0105 subjects
FG0115 subjects
FG0125 subjects
FG01310 subjects
FG0149 subjects
FG01513 subjectsN=11 randomized to Arm P. An additional N=2 (randomized to Arm O) are counted as Started in Arm P
FG01610 subjects
FG01711 subjects
FG0183 subjects
FG0195 subjects
FG0205 subjects
FG0215 subjects
FG0226 subjectsN=5 randomized to Arm W. An additional N=1 (randomized to Arm Q) is counted as Started in Arm W
FG0235 subjects
Treated
All participants as treated
FG0005 subjects
FG00111 subjects
FG00211 subjects
FG00311 subjects
FG00411 subjects
FG00510 subjects
FG0063 subjects
FG0075 subjects
FG0084 subjects
FG0095 subjects
FG0105 subjects
FG0115 subjects
FG0125 subjects
FG01310 subjects
FG0149 subjects
FG01513 subjectsN=2 (randomized to Arm O) rec'd 8 mg/kg Sugammadex, 3 min after 1.2 mg/kg Esmeron®
FG01610 subjects
FG01711 subjects
FG0183 subjects
FG0195 subjects
FG0205 subjects
FG0215 subjects
FG0226 subjectsN=1 (randomized to Arm Q) rec'd 12 mg/kg Sugammadex, 29 min after 1.2 mg/kg Esmeron®
FG0235 subjects
COMPLETED
FG0005 subjects
FG00111 subjects
FG00211 subjects
FG00311 subjects
FG00411 subjects
FG00510 subjects
FG0063 subjects
FG0075 subjects
FG0084 subjects
FG0094 subjects
FG0105 subjects
FG0115 subjects
FG0125 subjects
FG01310 subjects
FG0149 subjects
FG01513 subjects
FG01610 subjects
FG01711 subjects
FG0183 subjects
FG0195 subjects
FG0205 subjects
FG0214 subjects
FG0226 subjects
FG0235 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0211 subjects
FG0220 subjects
FG0230 subjects
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
BG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
BG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
BG024
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG00111
BG00211
BG00311
BG00411
BG00510
BG0063
BG0075
BG0084
BG0095
BG0105
BG0115
BG0125
BG01310
BG0149
BG01513
BG01610
BG01711
BG0183
BG0195
BG0205
BG0215
BG0226
BG0235
BG024173
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00049.8± 16.0
BG00145.8± 17.9
BG00248.4± 16.3
BG003
Sex: Female, Male
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG001
Race (NIH/OMB)
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation. Additionally, N=1 participant was excluded from Arm M due to missing data and N=1 participant was excluded from Arm N due to unreliability of the neuromuscular data.
Posted
Mean
Standard Deviation
minutes
Up to 240 minutes following administration of study treatment
ID
Title
Description
OG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
OG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
Units
Counts
Participants
OG0005
OG00111
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG000108.43± 31.17
OG00144.73± 22.18
OG0026.93± 2.87
OG003
Secondary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.
Posted
Mean
Standard Deviation
minutes
Up to 200 minutes following administration of study treatment
ID
Title
Description
OG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
OG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Secondary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.
Posted
Mean
Standard Deviation
minutes
Up to 180 minutes following administration of study treatment
ID
Title
Description
OG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
OG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Secondary
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
Posted
Count of Participants
Participants
Up to 7 days following administration of study treatment
ID
Title
Description
OG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®.
OG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG002
Time Frame
Up to 7 days following administration of study treatment
Description
Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A. Placebo; 3 Min After 1 mg/kg Esmeron
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
5
0
5
5
5
EG001
Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
11
1
11
5
11
EG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
11
0
11
7
11
EG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
11
1
11
7
11
EG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
11
0
11
8
11
EG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
10
3
10
6
10
EG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
3
0
3
2
3
EG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
5
0
5
4
5
EG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
4
0
4
3
4
EG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
5
0
5
4
5
EG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
5
0
5
3
5
EG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
0
5
1
5
4
5
EG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
5
1
5
3
5
EG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
10
0
10
5
10
EG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
9
2
9
7
9
EG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
13
0
13
5
13
EG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
10
1
10
6
10
EG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
11
1
11
9
11
EG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
3
0
3
3
3
EG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
5
0
5
2
5
EG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
5
1
5
3
5
EG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
5
0
5
1
5
EG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
6
0
6
3
6
EG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
0
5
0
5
3
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected5 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected9 at risk
EG0150 events0 affected13 at risk
EG0160 events0 affected10 at risk
EG0170 events0 affected11 at risk
EG0180 events0 affected3 at risk
EG0190 events0 affected5 at risk
EG0201 events1 affected5 at risk
EG0210 events0 affected5 at risk
EG0220 events0 affected6 at risk
EG0230 events0 affected5 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia
Cardiac disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected5 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected9 at risk
EG0150 events0 affected13 at risk
EG0160 events0 affected10 at risk
EG0170 events0 affected11 at risk
EG0180 events0 affected3 at risk
EG0190 events0 affected5 at risk
EG0200 events0 affected5 at risk
EG0210 events0 affected5 at risk
EG0220 events0 affected6 at risk
EG0230 events0 affected5 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Eye irritation
Eye disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0013 events3 affected11 at risk
EG0022 events2 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 7.1
Systematic Assessment
EG0002 events2 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Chills
General disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Infusion site erythema
General disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Malaise
General disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Pain
General disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Airway complication of anaesthesia
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Delayed recovery from anaesthesia
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Post procedural pain
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected11 at risk
EG0022 events2 affected11 at risk
EG003
Procedural hypertension
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 7.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Blood pressure increased
Investigations
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Heart rate decreased
Investigations
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected11 at risk
EG003
Haematoma
Vascular disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA 7.1
Systematic Assessment
EG0002 events2 affected5 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA 7.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor recognizes the right of the investigators to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D000077122
Sugammadex
D012965
Sodium Chloride
D000077123
Rocuronium
Ancestor Terms
ID
Term
D047408
gamma-Cyclodextrins
D003505
Cyclodextrins
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D003912
Dextrins
D013213
Starch
D005936
Glucans
D011134
Polysaccharides
D002241
Carbohydrates
D002712
Chlorides
D006851
Hydrochloric Acid
D017606
Chlorine Compounds
D007287
Inorganic Chemicals
D017670
Sodium Compounds
D000732
Androstanols
D000731
Androstanes
D013256
Steroids
D000072473
Fused-Ring Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
46.8
± 11.3
BG00447.5± 12.8
BG00554.9± 17.5
BG00643.3± 5.7
BG00751.2± 18.9
BG00863.0± 6.2
BG00945.2± 17.3
BG01056.0± 8.9
BG01162.4± 7.9
BG01257.2± 13.2
BG01353.0± 16.2
BG01447.9± 21.1
BG01552.6± 12.6
BG01657.5± 14.6
BG01748.7± 15.4
BG01848.0± 28.0
BG01941.8± 21.3
BG02045.0± 17.0
BG02144.8± 19.8
BG02251.8± 10.3
BG02346.0± 22.4
BG02450.4± 15.6
3
BG0027
BG0037
BG0045
BG0057
BG0060
BG0072
BG0080
BG0091
BG0101
BG0115
BG0124
BG0136
BG0146
BG0153
BG0164
BG0176
BG0182
BG0191
BG0202
BG0211
BG0221
BG0234
BG02480
Male
BG0003
BG0018
BG0024
BG0034
BG0046
BG0053
BG0063
BG0073
BG0084
BG0094
BG0104
BG0110
BG0121
BG0134
BG0143
BG01510
BG0166
BG0175
BG0181
BG0194
BG0203
BG0214
BG0225
BG0231
BG02493
0
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
White
BG0005
BG00111
BG00211
BG00311
BG00410
BG00510
BG0063
BG0075
BG0084
BG0095
BG0105
BG0115
BG0125
BG01310
BG0149
BG01513
BG01610
BG01711
BG0183
BG0195
BG0205
BG0215
BG0225
BG0235
BG024171
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0221
BG0230
BG0242
OG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
11
OG00411
OG00510
OG0063
OG0075
OG0084
OG0095
OG0105
OG0115
OG0124
OG0139
OG0148
OG01511
OG01610
OG01711
OG0183
OG0195
OG0205
OG0215
OG0225
OG0235
2.40
± 1.17
OG0042.42± 2.12
OG0051.77± 1.13
OG006127.37± 92.77
OG0078.53± 1.12
OG0085.47± 3.13
OG0091.85± 0.55
OG0101.78± 0.87
OG0110.93± 0.13
OG012122.98± 28.47
OG01365.67± 24.58
OG01413.78± 7.63
OG0153.23± 0.98
OG0162.08± 0.85
OG0171.32± 0.42
OG018139.62± 79.88
OG01942.20± 29.33
OG0205.97± 2.47
OG0212.33± 0.30
OG0221.77± 1.18
OG0234.73± 6.68
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Units
Counts
Participants
OG0005
OG00111
OG00211
OG00311
OG00411
OG00510
OG0063
OG0075
OG0084
OG0095
OG0105
OG0115
OG0125
OG01310
OG0148
OG01511
OG01610
OG01711
OG0183
OG0195
OG0205
OG0215
OG0225
OG0235
Title
Denominators
Categories
Title
Measurements
OG00098.23± 28.82
OG00140.00± 20.47
OG0025.90± 2.40
OG0031.87± 0.73
OG0041.57± 1.35
OG0051.43± 0.97
OG00691.53± 43.73
OG0076.23± 1.23
OG0084.10± 2.60
OG0091.45± 0.43
OG0101.33± 0.50
OG0110.93± 0.13
OG012129.85± 39.48
OG01360.85± 21.13
OG0148.52± 2.80
OG0152.80± 1.02
OG0161.73± 0.82
OG0171.20± 0.27
OG018121.03± 63.07
OG01933.95± 23.02
OG0204.42± 1.38
OG0211.98± 0.27
OG0221.72± 1.07
OG0231.27± 0.60
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG002
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
Units
Counts
Participants
OG0005
OG00111
OG00211
OG00311
OG00411
OG00510
OG0063
OG0075
OG0084
OG0095
OG0105
OG0115
OG0125
OG01310
OG0148
OG01511
OG01610
OG01711
OG0183
OG0195
OG0205
OG0215
OG0225
OG0235
Title
Denominators
Categories
Title
Measurements
OG00091.58± 27.43
OG00136.43± 17.22
OG0024.55± 1.43
OG0031.58± 0.70
OG0041.13± 0.12
OG0051.27± 0.52
OG00681.70± 34.18
OG0075.28± 0.77
OG0083.28± 1.62
OG0091.25± 0.15
OG0101.28± 0.42
OG0110.93± 0.13
OG012122.90± 36.23
OG01354.43± 17.33
OG0147.45± 2.82
OG0152.42± 0.85
OG0161.62± 0.80
OG0171.18± 0.22
OG018111.37± 53.03
OG01924.15± 13.00
OG0203.08± 0.90
OG0211.58± 0.35
OG0221.67± 0.97
OG0231.22± 0.57
Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG003
Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG004
Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG005
Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG006
Arm G. Placebo; 15 Min After 1 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG007
Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG008
Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG009
Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG010
Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG011
Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®.
OG012
Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG013
Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG014
Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG015
Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG016
Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG017
Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG018
Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron®
Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG019
Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG020
Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG021
Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG022
Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.
OG023
Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron®
Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®.