A Bridging Trial Comparing Sugammadex (Org 25969) at Reap... | NCT00591409 | Trialant
NCT00591409
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Mar 1, 2019Actual
Enrollment
100Actual
Phase
Phase 2
Conditions
Anesthesia, General
Interventions
sugammadex
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00591409
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P05956
Secondary IDs
ID
Type
Description
Link
19.4.208A
Other Identifier
Organon Protocol Number
MK-8616-030
Other Identifier
Merck Protocol Number
Brief Title
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)
Official Title
A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2019
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
Jan 3, 2006Actual
Primary Completion Date
Sep 22, 2006Actual
Completion Date
Dec 18, 2006Actual
First Submitted Date
Dec 27, 2007
First Submission Date that Met QC Criteria
Jan 10, 2008
First Posted Date
Jan 11, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 17, 2018
Results First Submitted that Met QC Criteria
Sep 17, 2018
Results First Posted Date
Feb 8, 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
Feb 14, 2019
Last Update Posted Date
Mar 1, 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 establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese Participants
Detailed Description
For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex (Org 25969) has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium-induced neuromuscular blockade. The current trial P05956 was conducted in Japan and set up to establish the dose-response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Japanese participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were evaluated.
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
100Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Rocuronium + Placebo
Placebo Comparator
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Drug: Placebo
Rocuronium + 0.5 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Drug: sugammadex
Rocuronium + 1.0 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Rocuronium + 2.0 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Rocuronium + 4.0 mg/kg sugammadex
Interventions
Name
Type
Description
Arm Group Labels
Other Names
sugammadex
Drug
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)
Secondary Outcomes
Measure
Description
Time Frame
Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is of American Society of Anesthesiologists (ASA) class 1 - 3;
Is at least 20 years but under 65 years of age;
Japanese participants;
Is scheduled for elective surgery in supine position and under sevoflurane anesthesia, in need of administration of neuromuscular blocking agents (NMBAs), with an anticipated duration of about 1.5-3 hours;
Has given written informed consent.
Exclusion Criteria:
Participants in whom a difficult intubation because of anatomical malformations was expected;
Is known or suspected to have neuromuscular disorders impairing the effect of NMBAs and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Is known or suspected to have a (family) history of malignant hyperthermia;
Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Females who were pregnant;
Females not using birth control or using only oral contraception as birth control continuously;
Were breast-feeding;
Has already participated in P05956, or in another trial with sugammadex;
Has participated in another clinical trial within 6 months of entering into P05956
Takeda J, Iwasaki H, Yamakage M, Ozaki M, Kawamata M, Hatano Y, Yorozuya T, Miyakawa H, Kanmura Y. [Efficacy and safety of sugammadex (Org 25969) in reversing moderate neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1075-82. Japanese.
See Also Links
Label
URL
Click here to access a synopsis of the study results.
Japanese participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
FG001
Rocuronium + 0.5 mg/kg Sugammadex
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
Japan
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
Experimental
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Vecuronium + Placebo
Placebo Comparator
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Drug: Placebo
Vecuronium + 0.5 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Drug: sugammadex
Vecuronium + 1.0 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Vecuronium + 2.0 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Vecuronium + 4.0 mg/kg sugammadex
Experimental
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
Drug: sugammadex
Rocuronium + 0.5 mg/kg sugammadex
Rocuronium + 1.0 mg/kg sugammadex
Rocuronium + 2.0 mg/kg sugammadex
Rocuronium + 4.0 mg/kg sugammadex
Vecuronium + 0.5 mg/kg sugammadex
Vecuronium + 1.0 mg/kg sugammadex
Vecuronium + 2.0 mg/kg sugammadex
Vecuronium + 4.0 mg/kg sugammadex
Org 25969
Placebo
Drug
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of placebo IV was administered
Rocuronium + Placebo
Vecuronium + Placebo
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)
Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
FG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
FG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
FG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
FG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
FG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
FG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
FG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
FG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG0089 subjects
FG00911 subjects
Treated
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG0049 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG0089 subjects
FG00910 subjects
COMPLETED
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG0049 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG0089 subjects
FG00910 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
Type
Comment
Reasons
Not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
All Participants As Treated
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
BG001
Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
BG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
BG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
BG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
BG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
BG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
BG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
BG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
BG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG00310
BG0049
BG00510
BG00610
BG00710
BG0089
BG00910
BG01098
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00041± 10
BG00144± 10
BG00249± 9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
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
Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.
Posted
Mean
Standard Deviation
Minutes
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)
ID
Title
Description
OG000
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
OG001
Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
OG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
OG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Units
Counts
Participants
OG0006
OG0015
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00082.08± 27.57
OG0013.95± 2.50
OG0022.48± 1.28
OG003
Secondary
Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.
Posted
Mean
Standard Deviation
Minutes
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)
ID
Title
Description
OG000
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
OG001
Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Secondary
Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.
Posted
Mean
Standard Deviation
Minutes
Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)
ID
Title
Description
OG000
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
OG001
Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Time Frame
Up to 7 days after sugammadex or placebo treatment
Description
All participants as treated
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
Rocuronium + Placebo
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
0
10
0
10
10
10
EG001
Rocuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
0
10
0
10
10
10
EG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
0
10
0
10
10
10
EG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
0
10
1
10
9
10
EG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
0
9
0
9
8
9
EG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
0
10
0
10
10
10
EG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
0
10
1
10
9
10
EG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
0
10
0
10
9
10
EG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
0
9
0
9
9
9
EG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
0
10
0
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Glossodynia
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected10 at risk
Swollen tongue
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Intrauterine infection
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected10 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected10 at risk
Palpitations
Cardiac disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Corneal oedema
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Eye discharge
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Eye pain
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Eye swelling
Eye disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Gingival swelling
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0002 events2 affected10 at risk
EG0014 events4 affected10 at risk
EG0024 events4 affected10 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Palatal oedema
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Application site erythema
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Application site pruritus
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Catheter site pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Chest pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Discomfort
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Face oedema
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Feeling abnormal
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Gait disturbance
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Infusion site erythema
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Infusion site mass
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Injection site pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Instillation site pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Instillation site reaction
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Lower extremity mass
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Malaise
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oedema
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral coldness
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Puncture site pain
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 9.1
Systematic Assessment
EG0004 events4 affected10 at risk
EG0013 events3 affected10 at risk
EG0025 events5 affected10 at risk
EG003
Thirst
General disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Venipuncture site swelling
General disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cystitis
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Oral infection
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Agitation postoperative
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Anaesthetic complication cardiac
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Anxiety postoperative
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Endotracheal intubation complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Incision site haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events2 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Mental status changes postoperative
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral nerve injury
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Post procedural oedema
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Postoperative fever
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Procedural hypertension
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0008 events8 affected10 at risk
EG0017 events7 affected10 at risk
EG0027 events7 affected10 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Albumin urine present
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Beta 2 microglobulin increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Beta 2 microglobulin urine increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Blood pressure increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Blood urine present
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Body temperature decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Red blood cells urine positive
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Urine output decreased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
White blood cell count increased
Investigations
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0013 events3 affected10 at risk
EG0022 events2 affected10 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Intracranial hypotension
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Trigeminal palsy
Nervous system disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0023 events2 affected10 at risk
EG003
Tension
Psychiatric disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Genital pruritus female
Reproductive system and breast disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Vulval erythema
Reproductive system and breast disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pharyngolaryngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0023 events3 affected10 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Tracheal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Haematoma
Vascular disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Pallor
Vascular disorders
MedDRA 9.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 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
Any scientific paper, presentation, or other communication concerning this clinical trial 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
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
Browse Leaves
Not provided
Browse Branches
Not provided
45
± 10
BG00441± 15
BG00549± 14
BG00649± 8
BG00746± 13
BG00852± 13
BG00944± 14
BG01046± 12
5
BG0035
BG0047
BG0056
BG0065
BG0076
BG0085
BG0093
BG01054
Male
BG0005
BG0013
BG0025
BG0035
BG0042
BG0054
BG0065
BG0074
BG0084
BG0097
BG01044
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Not Hispanic or Latino
BG00010
BG00110
BG00210
BG00310
BG0049
BG00510
BG00610
BG00710
BG0089
BG00910
BG01098
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
OG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
OG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
7
OG0049
OG0057
OG0063
OG0078
OG0086
OG00910
2.17
± 1.23
OG0041.85± 1.17
OG00583.20± 20.63
OG00652.03± 64.92
OG00710.63± 19.23
OG0082.77± 0.83
OG0092.08± 0.90
OG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
OG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
OG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
OG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
Units
Counts
Participants
OG0007
OG0015
OG00210
OG0039
OG0049
OG0059
OG0064
OG0079
OG0088
OG00910
Title
Denominators
Categories
Title
Measurements
OG00052.60± 16.27
OG0012.35± 0.70
OG0021.73± 0.85
OG0031.23± 0.38
OG0041.20± 0.27
OG00585.85± 75.12
OG00612.52± 17.95
OG0072.87± 1.13
OG0082.30± 0.60
OG0091.33± 0.43
OG002
Rocuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG003
Rocuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG004
Rocuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
OG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
OG006
Vecuronium + 0.5 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
OG007
Vecuronium + 1.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
OG008
Vecuronium + 2.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
OG009
Vecuronium + 4.0 mg/kg Sugammadex
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.04 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.