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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8616-020 | Other Identifier | Merck Protocol Number | |
| 19.4.202 | Other Identifier | Organon Protocol Number |
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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A. Placebo; given 3 minutes after Esmeron® | Placebo Comparator | Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron® | Experimental | Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron® | Experimental | Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min). | Up to 70 minutes following administration of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 45 minutes prior to study treatment administration |
| Mean Heart Rate at 2 Minutes Following Administration of Study Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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®. |
| FG001 | Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm G. Placebo; given 5 minutes after Esmeron® | Placebo Comparator | Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron® | Experimental | Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron® | Experimental | Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm M. Placebo; given 15 minutes after Esmeron® | Placebo Comparator | Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron® | Experimental | Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron® | Experimental | Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron® | Experimental | Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron® | Experimental | Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron® | Experimental | Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
|
| Sugammadex | Drug | Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight. |
|
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| Esmeron® | Drug | Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight. |
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Mean heart rate at 2 minutes following administration of study treatment was assessed. |
| 2 minutes following administration of study treatment |
| Mean Heart Rate at 30 Minutes Following Administration of Study Treatment | Mean heart rate at 30 minutes following administration of study treatment was assessed. | 30 minutes following administration of study treatment |
| 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. | Up to 45 minutes prior to study treatment administration |
| 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. | 2 minutes following administration of study treatment |
| 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. | 30 minutes following administration of study treatment |
| Number of Participants Experiencing an Adverse Event | The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. | Up to 7 days following administration of study treatment |
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
| FG002 | 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®. |
| FG003 | 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®. |
| FG004 | 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®. |
| FG005 | 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®. |
| FG006 | 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®. |
| FG007 | 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®. |
| FG008 | 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®. |
| FG009 | 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®. |
| FG010 | 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®. |
| FG011 | 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®. |
| FG012 | 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®. |
| FG013 | 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®. |
| FG014 | 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®. |
| FG015 | 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®. |
| FG016 | 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®. |
| FG017 | 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®. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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®. |
| BG001 | 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®. |
| BG002 | 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®. |
| BG003 | 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®. |
| BG004 | 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®. |
| BG005 | 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®. |
| BG006 | 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®. |
| BG007 | 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®. |
| BG008 | 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®. |
| BG009 | 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®. |
| BG010 | 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®. |
| BG011 | 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®. |
| BG012 | 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®. |
| BG013 | 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®. |
| BG014 | 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®. |
| BG015 | 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®. |
| BG016 | 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®. |
| BG017 | 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®. |
| BG018 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||
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| 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). | Per protocol, includes all randomized participants receiving study treatment without major protocol violations, having data available for this outcome measure. | Posted | Mean | Standard Deviation | minutes | Up to 70 minutes following administration of study treatment |
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| 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. | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Up to 45 minutes prior to study treatment administration |
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| 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. | 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. | Posted | Mean | Standard Deviation | bpm | 2 minutes following administration of study treatment |
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| 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. | 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. | Posted | Mean | Standard Deviation | bpm | 30 minutes following administration of study treatment |
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| 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. | 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. | Posted | Mean | Standard Deviation | milliseconds (msec) | Up to 45 minutes prior to study treatment administration |
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| 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. | 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. | Posted | Mean | Standard Deviation | msec | 2 minutes following administration of study treatment |
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| 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. | 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. | Posted | Mean | Standard Deviation | msec | 30 minutes following administration of study treatment |
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| Secondary | Number of Participants Experiencing an Adverse Event | The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. | Includes all 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. | Posted | Count of Participants | Participants | Up to 7 days following administration of study treatment |
|
Up to 7 days following administration of study treatment
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A. Placebo; Given 3 Minutes After Esmeron | Placebo (single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | 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®. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | 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®. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | 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®. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | 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®. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | 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®. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | 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®. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG007 | 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®. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG008 | 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®. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG009 | 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®. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG010 | 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®. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG011 | 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®. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG012 | 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®. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG013 | 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®. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG014 | 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®. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG015 | 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®. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG016 | 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®. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG017 | 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®. | 0 | 6 | 0 | 6 | 3 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Therapeutic response decreased | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
The Sponsor recognizes the right of the investigators to publish, but all publications must be based on data validated by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077123 | Rocuronium |
| 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 |
Not provided
Not provided
| Male |
|
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
|
|
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
|
|
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
|
|
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
|
|
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
|
|
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. |
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
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| 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®. |
| OG003 | 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®. |
| OG004 | 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®. |
| OG005 | 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®. |
| OG006 | 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®. |
| OG007 | 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®. |
| OG008 | 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®. |
| OG009 | 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®. |
| OG010 | 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®. |
| OG011 | 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®. |
| OG012 | 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®. |
| OG013 | 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®. |
| OG014 | 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®. |
| OG015 | 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®. |
| OG016 | 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®. |
| OG017 | 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®. |
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