Trial Outcomes & Findings for Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699) (NCT NCT00724932)

NCT ID: NCT00724932

Last Updated: 2017-05-16

Results Overview

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 140 participants
• Primary outcome timeframe: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)
• Results posted on: 2017-05-16

Participant Flow

Participants were recruited from 10 sites in Germany, Russia, Finland and the United Kingdom between July 2008 and March 2009.

Participant milestones

Measure	Sugammadex Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)	Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
Overall Study STARTED	70	70
Overall Study COMPLETED	65	67
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Sugammadex Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)	Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
Overall Study Lost to Follow-up	1	0
Overall Study Not treated	4	3

Baseline Characteristics

Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

Baseline characteristics by cohort

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2	Total n=133 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 16 • n=5 Participants	51 years STANDARD_DEVIATION 14 • n=7 Participants	51 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)

Population: The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9	2.4 minutes Interval 2.1 to 2.7	8.4 minutes Interval 7.2 to 9.8

SECONDARY outcome

Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7	1.6 minutes Interval 1.5 to 1.8	4.1 minutes Interval 3.7 to 4.6

SECONDARY outcome

Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8	1.9 minutes Interval 1.7 to 2.1	5.6 minutes Interval 4.9 to 6.3

SECONDARY outcome

Timeframe: From signing of informed consent to end of trial (7 days after surgery)

Population: The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.

An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.

Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs Pre-treatment SAE	1 participants	0 participants
Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs Post-treatment SAE	4 participants	6 participants

SECONDARY outcome

Timeframe: From signing of informed consent to end of trial (7 days after surgery)

Population: The AST Population consisted of all randomized participants who received IMP.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs Pre-treatment non-serious AE	38 participants	34 participants
Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs Post-treatment non-serious AE	65 participants	65 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6 Recovery of T4/T1 Ratio to 0.5	1.3 minutes Interval 1.2 to 1.5	2.8 minutes Interval 2.5 to 3.1
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6 Recovery of T4/T1 Ratio to 0.6	1.5 minutes Interval 1.3 to 1.6	3.4 minutes Interval 3.1 to 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 Recovery of T4/T1 ratio to 0.5	11.7 minutes Interval 10.1 to 13.6	30.0 minutes Interval 26.2 to 34.4
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 Recovery of T4/T1 ratio to 0.6	11.9 minutes Interval 10.3 to 13.8	30.7 minutes Interval 26.8 to 35.1
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 Recovery of T4/T1 ratio to 0.7	12.1 minutes Interval 10.5 to 14.0	31.6 minutes Interval 27.7 to 36.0
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 Recovery of T4/T1 ratio to 0.8	12.5 minutes Interval 10.8 to 14.3	33.2 minutes Interval 29.2 to 37.9
Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 Recovery of T4/T1 ratio to 0.9 (N=65, N=61)	13.3 minutes Interval 11.6 to 15.3	35.2 minutes Interval 30.8 to 40.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)

Population: The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.

The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group	8.9 minutes Interval 7.3 to 10.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)

Population: The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.

The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.

Outcome measures

Measure	Sugammadex n=65 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group	25.6 minutes Interval 21.8 to 30.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Population: The AST Population consisted of all randomized participants who received IMP.

Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Mean Systolic Blood Pressure Screening	132.7 mm Hg Standard Deviation 17.7	133.9 mm Hg Standard Deviation 19.1
Mean Systolic Blood Pressure Pre-rocuronium	98.2 mm Hg Standard Deviation 13.9	101.6 mm Hg Standard Deviation 18.2
Mean Systolic Blood Pressure Pre-IMP	122.1 mm Hg Standard Deviation 16.5	121.3 mm Hg Standard Deviation 18.8
Mean Systolic Blood Pressure 2 minutes post-IMP (N=65, N=65)	122.5 mm Hg Standard Deviation 18.8	122.5 mm Hg Standard Deviation 20.4
Mean Systolic Blood Pressure 5 minutes post-IMP	122.6 mm Hg Standard Deviation 17.7	118.0 mm Hg Standard Deviation 22.3
Mean Systolic Blood Pressure 10 minutes post-IMP (N=66, N=66)	124.0 mm Hg Standard Deviation 17.8	119.3 mm Hg Standard Deviation 23.7
Mean Systolic Blood Pressure 30 minutes post-IMP (N=65, N=66)	132.9 mm Hg Standard Deviation 17.4	131.7 mm Hg Standard Deviation 23.0
Mean Systolic Blood Pressure Post-anesthetic visit (N=66, N=66)	127.3 mm Hg Standard Deviation 16.6	125.4 mm Hg Standard Deviation 17.1

OTHER_PRE_SPECIFIED outcome

Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Population: The AST Population consisted of all randomized participants who received IMP.

Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Mean Diastolic Blood Pressure Screening	80.9 mm Hg Standard Deviation 9.9	82.8 mm Hg Standard Deviation 9.4
Mean Diastolic Blood Pressure Pre-rocuronium	58.2 mm Hg Standard Deviation 11.6	58.3 mm Hg Standard Deviation 10.1
Mean Diastolic Blood Pressure Pre-IMP	72.8 mm Hg Standard Deviation 12.1	72.5 mm Hg Standard Deviation 12.8
Mean Diastolic Blood Pressure 2 minutes post-IMP (N=65, N=65)	73.4 mm Hg Standard Deviation 11.8	72.6 mm Hg Standard Deviation 11.8
Mean Diastolic Blood Pressure 5 minutes post-IMP	72.4 mm Hg Standard Deviation 11.4	69.2 mm Hg Standard Deviation 13.5
Mean Diastolic Blood Pressure 10 minutes post-IMP (N=66, N=66)	71.8 mm Hg Standard Deviation 12.8	68.7 mm Hg Standard Deviation 14.9
Mean Diastolic Blood Pressure 30 minutes post-IMP (N=65, N=66)	74.3 mm Hg Standard Deviation 10.9	73.1 mm Hg Standard Deviation 13.5
Mean Diastolic Blood Pressure Post-anesthetic visit (N=66, N=66)	76.7 mm Hg Standard Deviation 9.4	75.2 mm Hg Standard Deviation 10.8

OTHER_PRE_SPECIFIED outcome

Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Population: The AST Population consisted of all randomized participants who received IMP.

Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Mean Heart Rate Screening	72.9 beats per minute Standard Deviation 11.0	74.6 beats per minute Standard Deviation 11.4
Mean Heart Rate Pre-rocuronium	63.4 beats per minute Standard Deviation 13.4	63.6 beats per minute Standard Deviation 12.4
Mean Heart Rate Pre-IMP	68.3 beats per minute Standard Deviation 11.0	68.0 beats per minute Standard Deviation 12.3
Mean Heart Rate 2 minutes post-IMP (N=65, N=65)	66.0 beats per minute Standard Deviation 12.4	65.3 beats per minute Standard Deviation 12.4
Mean Heart Rate 5 minutes post-IMP	64.9 beats per minute Standard Deviation 12.3	57.1 beats per minute Standard Deviation 10.8
Mean Heart Rate 10 minutes post-IMP (N=66, N=66)	67.3 beats per minute Standard Deviation 12.4	56.3 beats per minute Standard Deviation 11.4
Mean Heart Rate 30 minutes post-IMP (N=65, N=66)	73.1 beats per minute Standard Deviation 12.2	65.1 beats per minute Standard Deviation 11.2
Mean Heart Rate Post-anesthetic visit (N=66, N=66)	72.7 beats per minute Standard Deviation 11.7	71.9 beats per minute Standard Deviation 71.9

OTHER_PRE_SPECIFIED outcome

Timeframe: At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)

Population: The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.

Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From induction of anesthesia to recovery from NMB (up to ~3 hours)

Population: The AST Population consisted of all randomized participants who received IMP.

Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 minutes after IMP administration

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 hours after IMP administration

Population: The AST Population consisted of all randomized participants who received IMP.

Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)	1 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 7 days after IMP administration

Population: The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.

Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium	0 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to PACU discharge (up to ~4.5 hours)

Population: The AST Population consisted of all randomized participants who received IMP.

The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites	NA participants This was a site-specific outcome measure. Data were collected at each site, but were not collected on a case report form and were not analyzed.	NA participants This was a site-specific outcome measure. Data were collected at each site, but were not collected on a case report form and were not analyzed.

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days after IMP administration

Population: The AST Population consisted of all randomized participants who received IMP.

Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Operating Room admission to Operating Room discharge ready (up to ~3 hours)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Operating Room Admission to Operating Room Discharge Ready	154 minutes Standard Deviation 46 • Interval 137.0 to 159.0	165 minutes Standard Deviation 55 • Interval 144.0 to 170.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From Operating Room admission to actual Operating Room discharge (up to ~3 hours)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Operating Room Admission to Actual Operating Room Discharge	158 minutes Standard Deviation 47	169 minutes Standard Deviation 58

OTHER_PRE_SPECIFIED outcome

Timeframe: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Operating Room Discharge Ready to Actual Operating Room Discharge	4 minutes Standard Deviation 5	5 minutes Standard Deviation 6

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.

The time of IMP administration was defined as the actual time at which IMP administration was started.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of IMP administration to tracheal extubation (up to ~21 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of IMP Administration to Tracheal Extubation	14 minutes Standard Deviation 8	21 minutes Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of IMP Administration to Operating Room Discharge Ready	15 minutes Standard Deviation 8	21 minutes Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Start of IMP Administration to Actual Operating Room Discharge	19 minutes Standard Deviation 9	26 minutes Standard Deviation 13

OTHER_PRE_SPECIFIED outcome

Timeframe: From tracheal extubation to Operating Room discharge ready (up to ~1 minute)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Tracheal Extubation to Operating Room Discharge Ready	1 minutes Standard Deviation 6	0 minutes Standard Deviation 6

OTHER_PRE_SPECIFIED outcome

Timeframe: From tracheal extubation to actual OR discharge (up to ~5 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Tracheal Extubation to Actual Operating Room Discharge	5 minutes Standard Deviation 7	5 minutes Standard Deviation 6

OTHER_PRE_SPECIFIED outcome

Timeframe: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready	28 minutes Standard Deviation 27	33 minutes Standard Deviation 40

OTHER_PRE_SPECIFIED outcome

Timeframe: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=65 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Operating Room Discharge Ready to Actual PACU Discharge	268 minutes Standard Deviation 348	210 minutes Standard Deviation 283

OTHER_PRE_SPECIFIED outcome

Timeframe: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Actual Operating Room Discharge to PACU Discharge Ready	24 minutes Standard Deviation 28	29 minutes Standard Deviation 40

OTHER_PRE_SPECIFIED outcome

Timeframe: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From Actual Operating Room Discharge to Actual PACU Discharge	264 minutes Standard Deviation 347	207 minutes Standard Deviation 284

OTHER_PRE_SPECIFIED outcome

Timeframe: From PACU admit to PACU discharge ready (up to ~25 minutes)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From PACU Admit to PACU Discharge Ready	20 minutes Standard Deviation 28	25 minutes Standard Deviation 40

OTHER_PRE_SPECIFIED outcome

Timeframe: From PACU admit to actual PACU discharge (up to ~4.3 hours)

Population: The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.

Outcome measures

Measure	Sugammadex n=66 Participants Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=64 Participants Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Time From PACU Admit to Actual PACU Discharge	260 minutes Standard Deviation 347	203 minutes Standard Deviation 284

Adverse Events

Sugammadex

Serious events: 5 serious events

Other events: 64 other events

Deaths: 0 deaths

Neostigmine

Serious events: 6 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sugammadex n=66 participants at risk Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 participants at risk Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
Gastrointestinal disorders Colitis	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	0.00% 0/67 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Post procedural complication	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural nausea	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	0.00% 0/67 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural vomiting	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	0.00% 0/67 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Musculoskeletal and connective tissue disorders Muscle rigidity	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	0.00% 0/67 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Nervous system disorders Sedation	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Vascular disorders Vascular calcification	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	0.00% 0/67 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Vascular disorders Vascular thrombosis limb	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	1.5% 1/67 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.

Other adverse events

Measure	Sugammadex n=66 participants at risk Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC	Neostigmine n=67 participants at risk Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
Gastrointestinal disorders Abdominal Pain	7.6% 5/66 • Number of events 5 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	6.0% 4/67 • Number of events 4 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Constipation	9.1% 6/66 • Number of events 6 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	4.5% 3/67 • Number of events 3 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Dry mouth	0.00% 0/66 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	6.0% 4/67 • Number of events 4 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Flatulence	3.0% 2/66 • Number of events 2 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	6.0% 4/67 • Number of events 4 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Nausea	24.2% 16/66 • Number of events 17 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	17.9% 12/67 • Number of events 13 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Gastrointestinal disorders Vomiting	12.1% 8/66 • Number of events 8 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	10.4% 7/67 • Number of events 7 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Anaesthetic complication cardiac	1.5% 1/66 • Number of events 1 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	13.4% 9/67 • Number of events 9 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural nausea	4.5% 3/66 • Number of events 3 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	7.5% 5/67 • Number of events 5 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural pain	90.9% 60/66 • Number of events 70 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	89.6% 60/67 • Number of events 72 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Injury, poisoning and procedural complications Procedural vomiting	4.5% 3/66 • Number of events 3 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	7.5% 5/67 • Number of events 5 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Investigations C-reactive protein increased	12.1% 8/66 • Number of events 8 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	9.0% 6/67 • Number of events 6 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.6% 5/66 • Number of events 5 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.	4.5% 3/67 • Number of events 3 • Up to 7 days after IMP administration The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place