Neuromuscular Blockade
Conditions
Brief summary
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.
Interventions
DRUGPlacebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).
DRUGSugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.
DRUGEsmeron®
Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Participants of ASA class 1 to 2. * Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.
Exclusion criteria
* Participants in whom a difficult intubation because of anatomical malformations is expected. * Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction. * Participants known or suspected to have a (family) history of malignant hyperthermia. * Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia. * Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg\^2+. * Participants who have already participated in this trial. * Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | Up to 70 minutes following administration of study treatment | Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 2 minutes following administration of study treatment | Mean heart rate at 2 minutes following administration of study treatment was assessed. |
| Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 30 minutes following administration of study treatment | Mean heart rate at 30 minutes following administration of study treatment was assessed. |
| Mean Corrected QT Interval (QTc) at Baseline | Up to 45 minutes prior to study treatment administration | Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate. |
| Mean Heart Rate at Baseline | Up to 45 minutes prior to study treatment administration | Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment. |
| Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 30 minutes following administration of study treatment | Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate. |
| Number of Participants Experiencing an Adverse Event | Up to 7 days following administration of study treatment | The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. |
| Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 2 minutes following administration of study treatment | Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate. |
Participant flow
Recruitment details
Of the N=99 randomized participants, N=98 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.
Pre-assignment details
One participant originally randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. As a result, this participant is counted as Started/Treated in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
Participants by arm
| Arm | Count |
|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 4 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 4 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 3 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 3 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 6 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Technical Error | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm A. Placebo; Given 3 Minutes After Esmeron® | Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Arm G. Placebo; Given 5 Minutes After Esmeron® | Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Arm M. Placebo; Given 15 Minutes After Esmeron® | Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 12.1 | 35.5 Years STANDARD_DEVIATION 14 | 35.8 Years STANDARD_DEVIATION 16.2 | 41.3 Years STANDARD_DEVIATION 11.6 | 34.3 Years STANDARD_DEVIATION 9.3 | 39.0 Years STANDARD_DEVIATION 7.7 | 38.7 Years STANDARD_DEVIATION 18.6 | 35.0 Years STANDARD_DEVIATION 11.5 | 40.5 Years STANDARD_DEVIATION 12.4 | 40.8 Years STANDARD_DEVIATION 8.4 | 38.7 Years STANDARD_DEVIATION 11.9 | 31.5 Years STANDARD_DEVIATION 11.8 | 33.0 Years STANDARD_DEVIATION 5.6 | 48.3 Years STANDARD_DEVIATION 11.6 | 39.8 Years STANDARD_DEVIATION 17.2 | 41.7 Years STANDARD_DEVIATION 13.6 | 36.0 Years STANDARD_DEVIATION 12.1 | 40.2 Years STANDARD_DEVIATION 15.8 | 38.9 Years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 4 | 5 / 6 | 1 / 4 | 4 / 6 | 4 / 6 | 5 / 6 | 2 / 3 | 2 / 6 | 1 / 6 | 3 / 6 | 2 / 6 | 2 / 6 | 0 / 3 | 4 / 6 | 4 / 6 | 1 / 6 | 1 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min).
Time frame: Up to 70 minutes following administration of study treatment
Population: Per protocol, includes all randomized participants receiving study treatment without major protocol violations, having data available for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 52.05 minutes | Standard Deviation 8.77 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 22.73 minutes | Standard Deviation 11.58 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 4.93 minutes | Standard Deviation 1.25 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 6.25 minutes | Standard Deviation 9 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.85 minutes | Standard Deviation 0.62 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.83 minutes | Standard Deviation 0.87 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 51.67 minutes | Standard Deviation 13.13 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 27.35 minutes | Standard Deviation 6.35 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 8.88 minutes | Standard Deviation 7.8 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.28 minutes | Standard Deviation 0.73 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.13 minutes | Standard Deviation 0.93 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.45 minutes | Standard Deviation 0.6 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 35.58 minutes | Standard Deviation 9.05 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 6.53 minutes | Standard Deviation 1.73 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.73 minutes | Standard Deviation 0.72 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.05 minutes | Standard Deviation 1.18 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.08 minutes | Standard Deviation 1.97 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.35 minutes | Standard Deviation 0.2 |
Secondary
Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate.
Time frame: 2 minutes following administration of study treatment
Population: All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 420 msec | Standard Deviation 13.7 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 406 msec | Standard Deviation 11.8 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 422 msec | Standard Deviation 17 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 406 msec | Standard Deviation 24.7 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 427 msec | Standard Deviation 10.5 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 416 msec | Standard Deviation 14.5 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 400 msec | Standard Deviation 27.5 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 420 msec | Standard Deviation 16.3 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 412 msec | Standard Deviation 16.6 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 419 msec | Standard Deviation 20.3 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 410 msec | Standard Deviation 24.9 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 416 msec | Standard Deviation 20.2 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 401 msec | Standard Deviation 4.2 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 419 msec | Standard Deviation 15.6 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 406 msec | Standard Deviation 12.9 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 416 msec | Standard Deviation 26.5 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 410 msec | Standard Deviation 31.8 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment | 416 msec | Standard Deviation 16.8 |
Secondary
Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment
Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate.
Time frame: 30 minutes following administration of study treatment
Population: All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 418 msec | Standard Deviation 11.6 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 416 msec | Standard Deviation 17.6 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 427 msec | Standard Deviation 13.2 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 415 msec | Standard Deviation 21.7 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 433 msec | Standard Deviation 21.6 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 424 msec | Standard Deviation 27 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 392 msec | Standard Deviation 21.1 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 420 msec | Standard Deviation 21.3 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 425 msec | Standard Deviation 19.6 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 413 msec | Standard Deviation 21.9 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 400 msec | Standard Deviation 27.4 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 422 msec | Standard Deviation 14.4 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 400 msec | Standard Deviation 6.8 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 418 msec | Standard Deviation 18.5 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 408 msec | Standard Deviation 14.6 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 421 msec | Standard Deviation 33.8 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 411 msec | Standard Deviation 25.3 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment | 418 msec | Standard Deviation 22 |
Secondary
Mean Corrected QT Interval (QTc) at Baseline
Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)\^(1/3). RR interval = 60/heart rate.
Time frame: Up to 45 minutes prior to study treatment administration
Population: All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 418 milliseconds (msec) | Standard Deviation 2.5 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 396 milliseconds (msec) | Standard Deviation 11.3 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 418 milliseconds (msec) | Standard Deviation 17.8 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 404 milliseconds (msec) | Standard Deviation 20.7 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 417 milliseconds (msec) | Standard Deviation 13.1 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 416 milliseconds (msec) | Standard Deviation 20.4 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 400 milliseconds (msec) | Standard Deviation 23.9 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 415 milliseconds (msec) | Standard Deviation 19.6 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 405 milliseconds (msec) | Standard Deviation 15.7 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 416 milliseconds (msec) | Standard Deviation 21.7 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 408 milliseconds (msec) | Standard Deviation 22.2 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 411 milliseconds (msec) | Standard Deviation 13.9 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 392 milliseconds (msec) | Standard Deviation 13.9 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 410 milliseconds (msec) | Standard Deviation 11.8 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 398 milliseconds (msec) | Standard Deviation 14.5 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 398 milliseconds (msec) | Standard Deviation 23.6 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 398 milliseconds (msec) | Standard Deviation 24.8 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Corrected QT Interval (QTc) at Baseline | 406 milliseconds (msec) | Standard Deviation 25.4 |
Secondary
Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
Mean heart rate at 2 minutes following administration of study treatment was assessed.
Time frame: 2 minutes following administration of study treatment
Population: All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 76.7 bpm | Standard Deviation 18.6 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 73.0 bpm | Standard Deviation 15 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 84.5 bpm | Standard Deviation 12 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 72.7 bpm | Standard Deviation 12.1 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 86.2 bpm | Standard Deviation 15.5 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 74.8 bpm | Standard Deviation 17.7 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 84.0 bpm | Standard Deviation 15.1 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 61.3 bpm | Standard Deviation 11.2 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 70.8 bpm | Standard Deviation 13.7 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 66.2 bpm | Standard Deviation 9.8 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 69.8 bpm | Standard Deviation 21.3 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 67.8 bpm | Standard Deviation 10.2 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 59.0 bpm | Standard Deviation 1.4 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 71.2 bpm | Standard Deviation 12.9 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 77.2 bpm | Standard Deviation 16.5 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 62.8 bpm | Standard Deviation 5 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 65.4 bpm | Standard Deviation 14.7 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 2 Minutes Following Administration of Study Treatment | 64.3 bpm | Standard Deviation 5.4 |
Secondary
Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
Mean heart rate at 30 minutes following administration of study treatment was assessed.
Time frame: 30 minutes following administration of study treatment
Population: All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 77.8 bpm | Standard Deviation 8.6 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 62.0 bpm | Standard Deviation 2.8 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 72.0 bpm | Standard Deviation 7.8 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 72.5 bpm | Standard Deviation 9.6 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 76.7 bpm | Standard Deviation 11.2 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 66.6 bpm | Standard Deviation 15.2 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 77.3 bpm | Standard Deviation 9.5 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 63.0 bpm | Standard Deviation 12.6 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 69.7 bpm | Standard Deviation 11.4 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 72.5 bpm | Standard Deviation 17.1 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 66.5 bpm | Standard Deviation 23.9 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 60.0 bpm | Standard Deviation 4 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 65.7 bpm | Standard Deviation 16.8 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 66.8 bpm | Standard Deviation 11.5 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 65.3 bpm | Standard Deviation 10.8 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 63.5 bpm | Standard Deviation 7.9 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 64.7 bpm | Standard Deviation 14.3 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | 66.0 bpm | Standard Deviation 5.8 |
Secondary
Mean Heart Rate at Baseline
Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment.
Time frame: Up to 45 minutes prior to study treatment administration
Population: All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 61.0 beats per minute (bpm) | Standard Deviation 3.6 |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 62.0 beats per minute (bpm) | Standard Deviation 4.6 |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 63.5 beats per minute (bpm) | Standard Deviation 3.9 |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 68.0 beats per minute (bpm) | Standard Deviation 11.4 |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 68.2 beats per minute (bpm) | Standard Deviation 10.8 |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Mean Heart Rate at Baseline | 69.8 beats per minute (bpm) | Standard Deviation 18.5 |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 68.0 beats per minute (bpm) | Standard Deviation 10.6 |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 56.7 beats per minute (bpm) | Standard Deviation 10.9 |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 64.2 beats per minute (bpm) | Standard Deviation 10.5 |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 64.7 beats per minute (bpm) | Standard Deviation 7.2 |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 69.7 beats per minute (bpm) | Standard Deviation 21 |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Mean Heart Rate at Baseline | 57.5 beats per minute (bpm) | Standard Deviation 4.7 |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 63.0 beats per minute (bpm) | Standard Deviation 11.8 |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 62.7 beats per minute (bpm) | Standard Deviation 8.8 |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 65.3 beats per minute (bpm) | Standard Deviation 13.5 |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 64.2 beats per minute (bpm) | Standard Deviation 8.6 |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 66.5 beats per minute (bpm) | Standard Deviation 11.7 |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Mean Heart Rate at Baseline | 68.5 beats per minute (bpm) | Standard Deviation 9.4 |
Secondary
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Time frame: Up to 7 days following administration of study treatment
Population: Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A. Placebo; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 0 Participants |
| Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 1 Participants |
| Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm G. Placebo; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 1 Participants |
| Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm M. Placebo; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 0 Participants |
| Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 1 Participants |
| Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 1 Participants |
| Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |