Trial Outcomes & Findings for Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020). (NCT NCT03519854)

NCT ID: NCT03519854

Last Updated: 2019-04-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

Up to 70 minutes following administration of study treatment

Results posted on

2019-04-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.
Overall Study STARTED	4	6	5	6	6	6	3	6	6	6	6	6	3	6	6	6	6	6
Overall Study Treated	4	6	4	6	6	6	3	6	6	6	6	6	3	6	6	6	6	6
Overall Study COMPLETED	4	6	4	6	6	6	3	6	6	6	6	6	3	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.	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®.
Overall Study Technical Error	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=4 Participants 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® n=6 Participants 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® n=4 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Total n=98 Participants Total of all reporting groups
Age, Continuous	49.8 Years STANDARD_DEVIATION 12.1 • n=5 Participants • 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.	35.5 Years STANDARD_DEVIATION 14.0 • n=7 Participants • 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.	35.8 Years STANDARD_DEVIATION 16.2 • n=5 Participants • 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.	41.3 Years STANDARD_DEVIATION 11.6 • n=4 Participants • 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.	34.3 Years STANDARD_DEVIATION 9.3 • n=21 Participants • 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.	39.0 Years STANDARD_DEVIATION 7.7 • n=8 Participants • 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.	38.7 Years STANDARD_DEVIATION 18.6 • n=8 Participants • 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.	35.0 Years STANDARD_DEVIATION 11.5 • n=24 Participants • 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.	40.5 Years STANDARD_DEVIATION 12.4 • n=42 Participants • 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.	40.8 Years STANDARD_DEVIATION 8.4 • n=42 Participants • 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.	38.7 Years STANDARD_DEVIATION 11.9 • n=42 Participants • 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.	31.5 Years STANDARD_DEVIATION 11.8 • n=42 Participants • 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.	33.0 Years STANDARD_DEVIATION 5.6 • n=36 Participants • 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.	48.3 Years STANDARD_DEVIATION 11.6 • n=36 Participants • 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.	39.8 Years STANDARD_DEVIATION 17.2 • n=24 Participants • 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.	41.7 Years STANDARD_DEVIATION 13.6 • n=135 Participants • 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.	36.0 Years STANDARD_DEVIATION 12.1 • n=136 Participants • 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.	40.2 Years STANDARD_DEVIATION 15.8 • n=44 Participants • 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.	38.9 Years STANDARD_DEVIATION 12.3 • n=667 Participants • 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.
Sex: Female, Male Female	0 Participants n=5 Participants • 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.	0 Participants n=7 Participants • 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.	0 Participants n=5 Participants • 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.	0 Participants n=4 Participants • 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.	0 Participants n=21 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=8 Participants • 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.	0 Participants n=24 Participants • 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.	0 Participants n=42 Participants • 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.	0 Participants n=42 Participants • 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.	0 Participants n=42 Participants • 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.	0 Participants n=42 Participants • 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.	0 Participants n=36 Participants • 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.	0 Participants n=36 Participants • 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.	0 Participants n=24 Participants • 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.	0 Participants n=135 Participants • 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.	0 Participants n=136 Participants • 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.	0 Participants n=44 Participants • 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.	0 Participants n=667 Participants • 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.
Sex: Female, Male Male	4 Participants n=5 Participants • 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.	6 Participants n=7 Participants • 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.	4 Participants n=5 Participants • 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.	6 Participants n=4 Participants • 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.	6 Participants n=21 Participants • 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.	6 Participants n=8 Participants • 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.	3 Participants n=8 Participants • 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.	6 Participants n=24 Participants • 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.	6 Participants n=42 Participants • 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.	6 Participants n=42 Participants • 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.	6 Participants n=42 Participants • 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.	6 Participants n=42 Participants • 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.	3 Participants n=36 Participants • 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.	6 Participants n=36 Participants • 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.	6 Participants n=24 Participants • 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.	6 Participants n=135 Participants • 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.	6 Participants n=136 Participants • 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.	6 Participants n=44 Participants • 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.	98 Participants n=667 Participants • 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.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=3 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=5 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=5 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg 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	22.73 minutes Standard Deviation 11.58	4.93 minutes Standard Deviation 1.25	6.25 minutes Standard Deviation 9.00	1.85 minutes Standard Deviation 0.62	1.83 minutes Standard Deviation 0.87	51.67 minutes Standard Deviation 13.13	27.35 minutes Standard Deviation 6.35	8.88 minutes Standard Deviation 7.80	2.28 minutes Standard Deviation 0.73	2.13 minutes Standard Deviation 0.93	1.45 minutes Standard Deviation 0.60	35.58 minutes Standard Deviation 9.05	6.53 minutes Standard Deviation 1.73	2.73 minutes Standard Deviation 0.72	2.05 minutes Standard Deviation 1.18	2.08 minutes Standard Deviation 1.97	1.35 minutes Standard Deviation 0.20

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=3 Participants 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® n=5 Participants 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® n=4 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Heart Rate at Baseline	61.0 beats per minute (bpm) Standard Deviation 3.6	62.0 beats per minute (bpm) Standard Deviation 4.6	63.5 beats per minute (bpm) Standard Deviation 3.9	68.0 beats per minute (bpm) Standard Deviation 11.4	68.2 beats per minute (bpm) Standard Deviation 10.8	69.8 beats per minute (bpm) Standard Deviation 18.5	68.0 beats per minute (bpm) Standard Deviation 10.6	56.7 beats per minute (bpm) Standard Deviation 10.9	64.2 beats per minute (bpm) Standard Deviation 10.5	64.7 beats per minute (bpm) Standard Deviation 7.2	69.7 beats per minute (bpm) Standard Deviation 21.0	57.5 beats per minute (bpm) Standard Deviation 4.7	63.0 beats per minute (bpm) Standard Deviation 11.8	62.7 beats per minute (bpm) Standard Deviation 8.8	65.3 beats per minute (bpm) Standard Deviation 13.5	64.2 beats per minute (bpm) Standard Deviation 8.6	66.5 beats per minute (bpm) Standard Deviation 11.7	68.5 beats per minute (bpm) Standard Deviation 9.4

SECONDARY outcome

Timeframe: 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.

Mean heart rate at 2 minutes following administration of study treatment was assessed.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=3 Participants 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® n=5 Participants 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® n=4 Participants 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® n=6 Participants 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® n=5 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=5 Participants 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® n=6 Participants 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® n=2 Participants 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® n=5 Participants 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® n=5 Participants 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® n=6 Participants 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® n=5 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Heart Rate at 2 Minutes Following Administration of Study Treatment	76.7 bpm Standard Deviation 18.6	73.0 bpm Standard Deviation 15.0	84.5 bpm Standard Deviation 12.0	72.7 bpm Standard Deviation 12.1	86.2 bpm Standard Deviation 15.5	74.8 bpm Standard Deviation 17.7	84.0 bpm Standard Deviation 15.1	61.3 bpm Standard Deviation 11.2	70.8 bpm Standard Deviation 13.7	66.2 bpm Standard Deviation 9.8	69.8 bpm Standard Deviation 21.3	67.8 bpm Standard Deviation 10.2	59.0 bpm Standard Deviation 1.4	71.2 bpm Standard Deviation 12.9	77.2 bpm Standard Deviation 16.5	62.8 bpm Standard Deviation 5.0	65.4 bpm Standard Deviation 14.7	64.3 bpm Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Mean heart rate at 30 minutes following administration of study treatment was assessed.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=4 Participants 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® n=4 Participants 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® n=4 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=5 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Heart Rate at 30 Minutes Following Administration of Study Treatment	77.8 bpm Standard Deviation 8.6	62.0 bpm Standard Deviation 2.8	72.0 bpm Standard Deviation 7.8	72.5 bpm Standard Deviation 9.6	76.7 bpm Standard Deviation 11.2	66.6 bpm Standard Deviation 15.2	77.3 bpm Standard Deviation 9.5	63.0 bpm Standard Deviation 12.6	69.7 bpm Standard Deviation 11.4	72.5 bpm Standard Deviation 17.1	66.5 bpm Standard Deviation 23.9	60.0 bpm Standard Deviation 4.0	65.7 bpm Standard Deviation 16.8	66.8 bpm Standard Deviation 11.5	65.3 bpm Standard Deviation 10.8	63.5 bpm Standard Deviation 7.9	64.7 bpm Standard Deviation 14.3	66.0 bpm Standard Deviation 5.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=3 Participants 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® n=5 Participants 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® n=4 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Corrected QT Interval (QTc) at Baseline	418 milliseconds (msec) Standard Deviation 2.5	396 milliseconds (msec) Standard Deviation 11.3	418 milliseconds (msec) Standard Deviation 17.8	404 milliseconds (msec) Standard Deviation 20.7	417 milliseconds (msec) Standard Deviation 13.1	416 milliseconds (msec) Standard Deviation 20.4	400 milliseconds (msec) Standard Deviation 23.9	415 milliseconds (msec) Standard Deviation 19.6	405 milliseconds (msec) Standard Deviation 15.7	416 milliseconds (msec) Standard Deviation 21.7	408 milliseconds (msec) Standard Deviation 22.2	411 milliseconds (msec) Standard Deviation 13.9	392 milliseconds (msec) Standard Deviation 13.9	410 milliseconds (msec) Standard Deviation 11.8	398 milliseconds (msec) Standard Deviation 14.5	398 milliseconds (msec) Standard Deviation 23.6	398 milliseconds (msec) Standard Deviation 24.8	406 milliseconds (msec) Standard Deviation 25.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=3 Participants 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® n=5 Participants 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® n=4 Participants 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® n=6 Participants 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® n=5 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=5 Participants 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® n=6 Participants 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® n=2 Participants 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® n=5 Participants 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® n=5 Participants 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® n=6 Participants 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® n=5 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment	420 msec Standard Deviation 13.7	406 msec Standard Deviation 11.8	422 msec Standard Deviation 17.0	406 msec Standard Deviation 24.7	427 msec Standard Deviation 10.5	416 msec Standard Deviation 14.5	400 msec Standard Deviation 27.5	420 msec Standard Deviation 16.3	412 msec Standard Deviation 16.6	419 msec Standard Deviation 20.3	410 msec Standard Deviation 24.9	416 msec Standard Deviation 20.2	401 msec Standard Deviation 4.2	419 msec Standard Deviation 15.6	406 msec Standard Deviation 12.9	416 msec Standard Deviation 26.5	410 msec Standard Deviation 31.8	416 msec Standard Deviation 16.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A. Placebo; Given 3 Minutes After Esmeron® n=4 Participants 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® n=4 Participants 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® n=4 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.	Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® n=5 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=3 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants 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® n=6 Participants Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment	418 msec Standard Deviation 11.6	416 msec Standard Deviation 17.6	427 msec Standard Deviation 13.2	415 msec Standard Deviation 21.7	433 msec Standard Deviation 21.6	424 msec Standard Deviation 27.0	392 msec Standard Deviation 21.1	420 msec Standard Deviation 21.3	425 msec Standard Deviation 19.6	413 msec Standard Deviation 21.9	400 msec Standard Deviation 27.4	422 msec Standard Deviation 14.4	400 msec Standard Deviation 6.8	418 msec Standard Deviation 18.5	408 msec Standard Deviation 14.6	421 msec Standard Deviation 33.8	411 msec Standard Deviation 25.3	418 msec Standard Deviation 22.0

SECONDARY outcome

Timeframe: 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.

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.