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=93 Participants	54 years n=4 Participants	55 years n=27 Participants
Sex: Female, Male Female	62 Participants n=93 Participants	69 Participants n=4 Participants	131 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	32 Participants n=4 Participants	70 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=93 Participants	94 Participants n=4 Participants	188 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	7 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) White	86 Participants n=93 Participants	73 Participants n=4 Participants	159 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	10 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment United States	100 Participants n=93 Participants	101 Participants n=4 Participants	201 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 day

Determine 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: echeverg@mskcc.org

Results disclosure agreements

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