Trial Outcomes & Findings for Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant (NCT NCT03116997)
NCT ID: NCT03116997
Last Updated: 2025-05-18
Results Overview
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
1 day
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
Neuromuscular Blockade Reversed With Neostigmine/Gly
Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
|
Neuromuscular Blockade Reversed With Sugammadex
Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
101
|
|
Overall Study
COMPLETED
|
100
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Baseline characteristics by cohort
| Measure |
Neuromuscular Blockade Reversed With Neostigmine/Gly
n=100 Participants
Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
|
Neuromuscular Blockade Reversed With Sugammadex
n=101 Participants
Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
54 years
n=107 Participants
|
55 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayDetermine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Outcome measures
| Measure |
Neuromuscular Blockade Reversed With Neostigmine/Gly
n=100 Participants
Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
|
Neuromuscular Blockade Reversed With Sugammadex
n=101 Participants
Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex
|
|---|---|---|
|
Measure Participants' Recovery Time Post-Surgery
|
3.59 hours
Interval 2.49 to 5.09
|
3.62 hours
Interval 2.8 to 5.87
|
Adverse Events
Neuromuscular Blockade Reversed With Neostigmine/Gly
Serious events: 2 serious events
Other events: 0 other events
Deaths: 14 deaths
Neuromuscular Blockade Reversed With Sugammadex
Serious events: 2 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Neuromuscular Blockade Reversed With Neostigmine/Gly
n=100 participants at risk
Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
|
Neuromuscular Blockade Reversed With Sugammadex
n=101 participants at risk
Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
1.0%
1/100 • 1 year
|
2.0%
2/101 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • 1 year
|
0.00%
0/101 • 1 year
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
1.0%
1/100 • 1 year
|
0.00%
0/101 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • 1 year
|
0.00%
0/101 • 1 year
|
|
Injury, poisoning and procedural complications
Kidney anastomotic leak
|
0.00%
0/100 • 1 year
|
0.99%
1/101 • 1 year
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
0.00%
0/100 • 1 year
|
2.0%
2/101 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/100 • 1 year
|
0.99%
1/101 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/100 • 1 year
|
0.99%
1/101 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. German Echeverry, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place