Trial Outcomes & Findings for Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications (NCT NCT03679611)
NCT ID: NCT03679611
Last Updated: 2025-03-20
Results Overview
The time from study drug administration to discharge from operating room (OR).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
15 minutes
Results posted on
2025-03-20
Participant Flow
120 patients were enrolled from January 14, 2019 to October 26, 2021. Study coordinators screened 237 patients for eligibility in the pre-operative and bariatric clinics at Toronto Western Hospital, University Health Network- a Bariatric Centre of Excellence located in Toronto, Ontario, Canada. Consenting patients were ≥18 years with OSA diagnosed by polysomnography for elective bariatric surgery under general anesthesia. Randomization was 1:1 into 2 groups of sugammadex vs. neostigmine.
A total of 237 patients were screened for eligibility in our study. 108 were excluded for not meeting study criteria. 9 were excluded for reasons like a hold on surgeries due to the coronavirus disease (COVID-19) pandemic or cancellations, unavailability of investigators on scheduled surgery days, etc. 120 patients were enrolled on the study and were subsequently randomized 1:1 into 2 groups of 60 patients each, given the study drug, and followed-up as per the study protocol.
Participant milestones
| Measure |
Interventional Arm
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is an FDA approved newer neuromuscular blocking drug (NMBD) reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Interventional Arm
n=60 Participants
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
n=60 Participants
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=60 Participants
|
60 Participants
n=60 Participants
|
120 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=120 Participants
|
|
Age, Continuous
|
49.50 Years
n=60 Participants
|
51.00 Years
n=60 Participants
|
50.50 Years
n=120 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=60 Participants
|
43 Participants
n=60 Participants
|
88 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=60 Participants
|
17 Participants
n=60 Participants
|
32 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 15 minutesPopulation: Same as baseline
The time from study drug administration to discharge from operating room (OR).
Outcome measures
| Measure |
Interventional Arm
n=60 Participants
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
n=60 Participants
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
|---|---|---|
|
Time to Discharge From Operating Room
|
13.0 Minutes
Interval 10.0 to 15.0
|
13.5 Minutes
Interval 11.0 to 15.0
|
SECONDARY outcome
Timeframe: 15 minutesPopulation: Same as baseline
Time from study drug administration to the patient open eyes to command.
Outcome measures
| Measure |
Interventional Arm
n=60 Participants
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
n=60 Participants
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
|---|---|---|
|
Time the Patient Open Eyes to Command
|
6.00 Minutes
Interval 4.0 to 10.0
|
7.00 Minutes
Interval 4.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minutesPopulation: Same as baseline
Time from study drug administration to extubation
Outcome measures
| Measure |
Interventional Arm
n=60 Participants
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
n=60 Participants
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
|---|---|---|
|
Time to Extubation
|
7.00 Minutes
Interval 5.0 to 11.0
|
8.00 Minutes
Interval 6.0 to 11.0
|
Adverse Events
Interventional Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Drug Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interventional Arm
n=60 participants at risk
Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses
Sugammadex Sodium: Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery
|
Standard Drug Arm
n=60 participants at risk
standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
Neostigmine: neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/60 • Adverse event data was collected when available through the course of study completion for each participant, an average of 1 day.
Standard definitions were used by the study for adverse events.
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected when available through the course of study completion for each participant, an average of 1 day.
Standard definitions were used by the study for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis left leg
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected when available through the course of study completion for each participant, an average of 1 day.
Standard definitions were used by the study for adverse events.
|
0.00%
0/60 • Adverse event data was collected when available through the course of study completion for each participant, an average of 1 day.
Standard definitions were used by the study for adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jean Wong, MD, FRCPC.
Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, University Health Network
Phone: 416-603-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place