Trial Outcomes & Findings for Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025) (NCT NCT00473694)

Last Updated: 2019-03-19

Results Overview

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

182 participants

Primary outcome timeframe

Up to approximately 3 hours after administration of study drug

Results posted on

2019-03-19

Participant Flow

The trial was conducted in 8 trial sites in the United States. A total of 182 participants were randomized with 157 participants treated.

Participant milestones

Participant milestones
Measure	Rocuronium+Sugammadex Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
Overall Study STARTED	48	41	51	42
Overall Study Treated	37	38	46	36
Overall Study COMPLETED	37	37	46	35
Overall Study NOT COMPLETED	11	4	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Rocuronium+Sugammadex Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
Overall Study Adverse Event	0	1	0	0
Overall Study Participants did not receive treatment	11	3	5	6
Overall Study Lost to Follow-up	0	0	0	1

Baseline Characteristics

The analysis population was all randomized participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rocuronium+Sugammadex n=48 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=40 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=52 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=42 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Total n=182 Participants Total of all reporting groups
Age, Continuous	53.6 Years STANDARD_DEVIATION 14.0 • n=93 Participants • The analysis population was all randomized participants.	54.0 Years STANDARD_DEVIATION 10.8 • n=4 Participants • The analysis population was all randomized participants.	49.9 Years STANDARD_DEVIATION 13.6 • n=27 Participants • The analysis population was all randomized participants.	55.2 Years STANDARD_DEVIATION 13.3 • n=483 Participants • The analysis population was all randomized participants.	53.0 Years STANDARD_DEVIATION 13.1 • n=36 Participants • The analysis population was all randomized participants.
Sex: Female, Male Female	26 Participants n=93 Participants • The analysis population was all randomized participants.	20 Participants n=4 Participants • The analysis population was all randomized participants.	33 Participants n=27 Participants • The analysis population was all randomized participants.	21 Participants n=483 Participants • The analysis population was all randomized participants.	100 Participants n=36 Participants • The analysis population was all randomized participants.
Sex: Female, Male Male	22 Participants n=93 Participants • The analysis population was all randomized participants.	20 Participants n=4 Participants • The analysis population was all randomized participants.	19 Participants n=27 Participants • The analysis population was all randomized participants.	21 Participants n=483 Participants • The analysis population was all randomized participants.	82 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants • The analysis population was all randomized participants.	0 Participants n=4 Participants • The analysis population was all randomized participants.	0 Participants n=27 Participants • The analysis population was all randomized participants.	0 Participants n=483 Participants • The analysis population was all randomized participants.	0 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) Asian	0 Participants n=93 Participants • The analysis population was all randomized participants.	3 Participants n=4 Participants • The analysis population was all randomized participants.	1 Participants n=27 Participants • The analysis population was all randomized participants.	3 Participants n=483 Participants • The analysis population was all randomized participants.	7 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants • The analysis population was all randomized participants.	0 Participants n=4 Participants • The analysis population was all randomized participants.	0 Participants n=27 Participants • The analysis population was all randomized participants.	0 Participants n=483 Participants • The analysis population was all randomized participants.	0 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants • The analysis population was all randomized participants.	1 Participants n=4 Participants • The analysis population was all randomized participants.	7 Participants n=27 Participants • The analysis population was all randomized participants.	2 Participants n=483 Participants • The analysis population was all randomized participants.	13 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) White	43 Participants n=93 Participants • The analysis population was all randomized participants.	36 Participants n=4 Participants • The analysis population was all randomized participants.	43 Participants n=27 Participants • The analysis population was all randomized participants.	37 Participants n=483 Participants • The analysis population was all randomized participants.	159 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) More than one race	0 Participants n=93 Participants • The analysis population was all randomized participants.	0 Participants n=4 Participants • The analysis population was all randomized participants.	0 Participants n=27 Participants • The analysis population was all randomized participants.	0 Participants n=483 Participants • The analysis population was all randomized participants.	0 Participants n=36 Participants • The analysis population was all randomized participants.
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants • The analysis population was all randomized participants.	0 Participants n=4 Participants • The analysis population was all randomized participants.	1 Participants n=27 Participants • The analysis population was all randomized participants.	0 Participants n=483 Participants • The analysis population was all randomized participants.	3 Participants n=36 Participants • The analysis population was all randomized participants.

PRIMARY outcome

Timeframe: Up to approximately 3 hours after administration of study drug

Population: The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium	3.28 Minutes Standard Deviation 2.40	55.50 Minutes Standard Deviation 27.10	—	—

PRIMARY outcome

Timeframe: Up to approximately 6 hours after administration of study drug

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium	8.73 Minutes Standard Deviation 14.60	77.80 Minutes Standard Deviation 56.98	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 hours after administration of study drug

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium	2.27 Minutes Standard Deviation 1.25	37.68 Minutes Standard Deviation 21.88	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 hours after administration of study drug

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium	4.10 Minutes Standard Deviation 8.78	56.17 Minutes Standard Deviation 36.65	—	—

SECONDARY outcome

Timeframe: Up to approximately 3 hours after administration of study drug

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium	2.65 Minutes Standard Deviation 1.58	45.82 Minutes Standard Deviation 24.95	—	—

SECONDARY outcome

Timeframe: Up to approximately 5 hours after administration of study drug

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium	5.55 Minutes Standard Deviation 9.87	67.42 Minutes Standard Deviation 44.85	—	—

SECONDARY outcome

Timeframe: Up to 24 hours

The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to transfer to recovery room	26 Participants	20 Participants	27 Participants	20 Participants
Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to discharge from recovery room	34 Participants	32 Participants	39 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to transfer to recovery room	9 Participants	11 Participants	12 Participants	8 Participants
Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to discharge from recovery room	0 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to transfer to recovery room	2 Participants	3 Participants	7 Participants	7 Participants
Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness) Prior to discharge from recovery room	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Number of Participants Able to Perform a 5-second Head Lift Prior to transfer to recovery room	33 Participants	28 Participants	36 Participants	24 Participants
Number of Participants Able to Perform a 5-second Head Lift Prior to discharge from recovery room	34 Participants	33 Participants	41 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment.

Outcome measures

Outcome measures
Measure	Rocuronium+Sugammadex n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=37 Participants Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=47 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 Participants Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Number of Participants Experiencing General Muscle Weakness Prior to transfer to recovery room	3 Participants	5 Participants	4 Participants	2 Participants
Number of Participants Experiencing General Muscle Weakness Prior to discharge from recovery room	2 Participants	3 Participants	1 Participants	3 Participants

Adverse Events

Rocuronium+Sugammadex

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Rocuronium+Neostigmine

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Vecuronium+Sugammadex

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Vecuronium+Neostigmine

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rocuronium+Sugammadex n=37 participants at risk Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Rocuronium+Neostigmine n=38 participants at risk Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.	Vecuronium+Sugammadex n=46 participants at risk Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.	Vecuronium+Neostigmine n=36 participants at risk Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Gastrointestinal disorders Gastric perforation	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Gastrointestinal disorders Nausea	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
General disorders Pain	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Infections and infestations Postoperative infection	2.7% 1/37 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/38 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Infections and infestations Splenic abscess	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/38 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.2% 1/46 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Injury, poisoning and procedural complications Postoperative ileus	2.7% 1/37 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Injury, poisoning and procedural complications Procedural complication	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/38 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.2% 1/46 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/37 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	2.6% 1/38 • Number of events 1 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/46 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).	0.00% 0/36 • Up to 7 days after administration of study drug The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All publications including scientific papers, presentations, or other communication concerning the clinical trial must first be submitted to the Sponsor at least six weeks ahead of estimated publication or presentation, for written consent. In order to protect proprietary interests, the Sponsor shall have the right to make consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.
Publication restrictions are in place

Restriction type: OTHER