Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults.
Ana-Marija Hristovska, Patricia Duch, Mikkel Allingstrup...
https://pubmed.ncbi.nlm.nih.gov/28806470Actively Recruiting
Led by University of California, Irvine · Updated on 2026-01-23
128
Participants Needed
1
Research Sites
4 weeks
Total Duration
U
University of California, Irvine
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
This research study focuses on patients undergoing colorectal surgery, specifically bowel resection, to compare the effects of two medications, Sugammadex and Neostigmine with Glycopyrrolate, on recovery after surgery. The study aims to measure how these drugs influence the time it takes for patients to have their first bowel movement and tolerate solid food, known as GI-2 recovery. The trial is a prospective, randomized, triple-blinded study designed to improve quality outcomes following bowel resection surgery. Participants will receive either Neostigmine plus Glycopyrrolate or Sugammadex injection to reverse neuromuscular blockade used during surgery. Neostigmine is given as 0.07 mg/kg with 0.014 mg/kg glycopyrrolate via two syringes, while Sugammadex is administered at 2.0 mg/kg along with saline in two syringes. Randomization is performed electronically, and the treatment assignments are blinded to patients, providers, and researchers. The study includes a comparison of these two active drugs following laparoscopic bowel resection under general anesthesia. During the study, participants will be monitored for the primary outcome of GI-2 recovery within 24 hours after surgery. Additional assessments include length and cost of hospital stay, morbidity and mortality rates up to 30 days, time spent in the post-anesthesia care unit, time to get out of bed, fluid administration during surgery, and occurrences of postoperative nausea and vomiting. Safety monitoring includes checking for bradycardia and bowel adhesions. The total participation duration varies with hospital stay and follow-up assessments up to 60 days.
CONDITIONS
Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours post surgery
Participants receive either Sugammadex or Neostigmine plus Glycopyrrolate to reverse neuromuscular blockade after bowel resection surgery.
1 surgery visit and monitoring until discharge from post-anesthesia care unit (PACU)
Duration - Up to 30 days post surgery for most outcomes, with some assessments up to 60 days
Participants are monitored for recovery outcomes including bowel function, morbidity, mortality, and post-operative complications.
Visits or assessments up to 30 days post surgery, with some up to 60 days
Total: 1 location
1
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
D
David Whaley
R
Robert R Field, MD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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