A Bridging Trial Comparing Sugammadex (Org 25969) at Reap... | NCT00552617 | Trialant
NCT00552617
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 25, 2019Actual
Enrollment
100Actual
Phase
Phase 2
Conditions
Anesthesia, General
Interventions
Sugammadex
Placebo
Rocuronium
Vecuronium
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00552617
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P05971
Secondary IDs
ID
Type
Description
Link
19.4.208B
Other Identifier
Organon Protocol Number
MK-8616-035
Other Identifier
Merck Protocol Number
2005-001133-15
EudraCT Number
Brief Title
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
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 B: Caucasian Subjects
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 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
Sep 20, 2005Actual
Primary Completion Date
Aug 31, 2006Actual
Completion Date
Aug 31, 2006Actual
First Submitted Date
Oct 31, 2007
First Submission Date that Met QC Criteria
Oct 31, 2007
First Posted Date
Nov 2, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2018
Results First Submitted that Met QC Criteria
Oct 1, 2018
Results First Posted Date
Feb 15, 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
Nov 13, 2019
Last Update Posted Date
Nov 25, 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 the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance 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) during sevoflurane anesthesia for Caucasian 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 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 P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be 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
Drug: Rocuronium
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
Drug: Rocuronium
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
Drug: Rocuronium
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sugammadex
Drug
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) 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 0.02-0.03 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;
Caucasian participants;
Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia 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 neuromuscular blocking (NMB) 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 of childbearing potential not using birth control or using only oral contraception as birth control;
Was breast-feeding;
Has already participated in P05971, or in another trial with sugammadex;
Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.
Caucasian 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
Austria
Belgium
Germany
Poland
Sweden
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
Single
Masking Description
Not provided
Who Masked
Outcomes Assessor
Drug: Sugammadex
Drug: Rocuronium
Rocuronium + 4.0 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 4.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Drug: Rocuronium
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Drug: Placebo
Drug: Vecuronium
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Drug: Vecuronium
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 1.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Drug: Vecuronium
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Drug: Vecuronium
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
Drug: Sugammadex
Drug: Vecuronium
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 (arm 1) or 0.1 mg/kg vecuronium (arm 6).
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 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
Rocuronium
Drug
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.
Rocuronium + 0.5 mg/kg Sugammadex
Rocuronium + 1.0 mg/kg Sugammadex
Rocuronium + 2.0 mg/kg Sugammadex
Rocuronium + 4.0 mg/kg Sugammadex
Rocuronium + Placebo
Vecuronium
Drug
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
Vecuronium + 0.5 mg/kg Sugammadex
Vecuronium + 1.0 mg/kg Sugammadex
Vecuronium + 2.0 mg/kg Sugammadex
Vecuronium + 4.0 mg/kg Sugammadex
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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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
FG00810 subjects
FG00910 subjects
Treated
FG00010 subjects
FG00110 subjects
FG0029 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG00810 subjects
FG0099 subjects
COMPLETED
FG00010 subjects
FG00110 subjects
FG0029 subjects
FG0039 subjects
FG00410 subjects
FG0058 subjects
FG00610 subjects
FG00710 subjects
FG0088 subjects
FG0099 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
Type
Comment
Reasons
Not Treated
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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
BG0029
BG00310
BG00410
BG00510
BG00610
BG00710
BG00810
BG0099
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
BG00050± 7
BG00152± 7
BG00250± 9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0018
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 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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
Units
Counts
Participants
OG0007
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00096.30± 33.13
OG00116.30± 20.60
OG0024.62± 5.97
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 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 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 randomized participants who received study treatment
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
9
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
9
0
9
6
9
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.
1
10
1
10
10
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
10
0
10
10
10
EG005
Vecuronium + Placebo
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV.
0
10
0
10
8
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 0.5 mg/kg sugammadex was administered IV.
0
10
2
10
10
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 0.02-0.03 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
6
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 2.0 mg/kg sugammadex was administered IV.
0
10
0
10
9
10
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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
0
9
0
9
7
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Large intestine perforation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected9 at risk
Bladder tamponade
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Urinary bladder haemorrhage
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected10 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected9 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0013 events3 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0015 events5 affected10 at risk
EG0023 events3 affected9 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0014 events4 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Catheter related complication
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Chills
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Feeling drunk
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hypothermia
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Infusion site swelling
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Oedema
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Ureteritis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Airway complication of anaesthesia
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Operative haemorrhage
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural nausea
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural vomiting
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Postoperative constipation
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Procedural hypertension
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0004 events4 affected10 at risk
EG0015 events5 affected10 at risk
EG0023 events3 affected9 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Beta 2 microglobulin increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Beta 2 microglobulin urine increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Beta-N-acetyl-D-glucosaminidase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Blood glucose increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Body temperature increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haptoglobin decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Heart rate increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Protein total decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Shoulder pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Migraine
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Paralysis
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Breath holding
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Bladder tamponade
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Genital pruritus female
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hypoventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Haemodynamic instability
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected9 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
D000077123
Rocuronium
D014673
Vecuronium Bromide
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
D000732
Androstanols
D000731
Androstanes
D013256
Steroids
D000072473
Fused-Ring Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
49
± 8
BG00449± 13
BG00548± 10
BG00647± 9
BG00746± 9
BG00845± 10
BG00947± 10
BG01048± 9
7
BG0035
BG0046
BG0058
BG0067
BG0077
BG0087
BG0097
BG01070
Male
BG0002
BG0012
BG0022
BG0035
BG0044
BG0052
BG0063
BG0073
BG0083
BG0092
BG01028
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Not Hispanic or Latino
BG00010
BG00110
BG0029
BG00310
BG00410
BG00510
BG00610
BG00710
BG00810
BG0099
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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.
9
OG0048
OG0058
OG0069
OG00710
OG0087
OG0099
1.43
± 0.50
OG0041.50± 0.40
OG00579.02± 25.97
OG00635.50± 42.13
OG0075.07± 2.38
OG0083.42± 1.85
OG0093.03± 2.18
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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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
OG00110
OG0028
OG0039
OG0049
OG0058
OG00610
OG00710
OG0089
OG0099
Title
Denominators
Categories
Title
Measurements
OG00065.67± 35.73
OG0013.08± 2.25
OG0022.08± 1.12
OG0031.12± 0.40
OG0041.02± 0.12
OG00558.12± 21.90
OG00612.57± 24.48
OG0072.35± 0.48
OG0082.00± 1.25
OG0091.70± 0.55
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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 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 0.02-0.03 mg/kg vecuronium IV if necessary. At reappearance of T2 a single dose of 4.0 mg/kg sugammadex was administered IV.