Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06112353

Sugammadex VS Neostigmine and Glycopyrrolate Reversal of Neuromuscular Relaxation for Time to Return of Bowel Function After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial for Quality Improvement

Led by University of California, Irvine · Updated on 2026-01-23

128

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of California, Irvine

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Scheduled for laparoscopic bowel resection surgery under general anesthesia using nondepolarizing neuromuscular blockade with rocuronium or vecuronium
  • Requires inpatient hospital admission
Not Eligible

You will not qualify if you...

  • Allergy to Rocuronium, Vecuronium, or Sugammadex
  • Bowel resection surgery requiring an ostomy
  • Presence of severe valvulopathy, systolic heart failure with reduced ejection fraction, or coronary artery disease with positive stress test for ischemic regional wall motion abnormality
  • Autoimmune pulmonary disease, severe pulmonary fibrosis, severe pulmonary hypertension, COPD requiring home oxygen, or pulmonary cancer
  • Creatinine Clearance less than 30
  • Pregnancy
  • Incapable of providing consent or understanding the research project

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

Trial Site Locations

Total: 1 location

1

UC Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

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Research Team

D

David Whaley

R

Robert R Field, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Evaluation of a U.S. National Cohort to Determine Utilization in Colectomy Rates for Ulcerative Colitis Among Ethnicities.

Abhishek Bhurwal, Carlos D Minacapelli, Anish Patel...

https://pubmed.ncbi.nlm.nih.gov/33534892

Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway.

Kirk Ludwig, Warren E Enker, Conor P Delaney...

https://pubmed.ncbi.nlm.nih.gov/19015469

Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy.

Atousa Deljou, Jalal Soleimani, Juraj Sprung...

https://pubmed.ncbi.nlm.nih.gov/34986061