Comparing Sugammadex and Neostigmine for Recovery After Bowel Surgery
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
This study is testing whether Sugammadex or Neostigmine helps people recover faster after bowel surgery by looking at how quickly they can have their first bowel movement and eat solid food.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06112353 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Sugammadex versus Neostigmine with Glycopyrrolate in facilitating recovery after laparoscopic bowel resection surgery. It focuses on measuring the time to the first bowel movement and the ability to tolerate solid food post-surgery. The research employs a randomized triple-blind design to ensure unbiased results, with participants randomly assigned to one of the two medication groups. The study is particularly relevant given the high number of colectomies performed annually in the U.S. for various intestinal diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older undergoing laparoscopic bowel resection surgery with specific anesthesia requirements.
Not a fit: Patients with allergies to the study medications, severe heart or pulmonary conditions, or those requiring an ostomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and better postoperative outcomes for patients undergoing bowel resection surgery.
How similar studies have performed: While there is limited prospective data on this specific comparison, similar studies have shown promising results with neuromuscular blockade reversal agents in surgical recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission Exclusion Criteria: * Allergy to Rocuronium, Vecuronium, or Sugammadex * Bowel resection surgery requiring an ostomy * No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality * No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin * Creatinine Clearance (CrCl) of less than 30 * Pregnancy * Incapable of providing consent or understanding the research project
Where this trial is running
Orange, California
- UC Irvine Medical Center — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Robert R Field, MD — Associate Clinical Professor
- Study coordinator: David Whaley
- Email: whaleyd@hs.uci.edu
- Phone: 714-456-5501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.