Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Robert R Field, MD

Description

Summary

The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

Official Title

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

Details

Neuromuscular blocking agents are essential during surgical procedures to paralyze the body to avoid unnecessary movement during surgery. There are various medications, such as Sugammadex that are later used to reverse the effects of the neuromuscular blockade. The U.S. performs approximately 320,000 colectomies per year for benign and malignant conditions such as Ulcerative Colitis (UC). Bowel resection surgery removes a portion of small or large intestine. Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (hour) to first bowel movement and tolerance for solid food (aka GI-2 recovery) following bowel resection surgery. The study team will be conducting a randomized triple-blind study (patient's assigned group is hidden from the patient, provider, and research team). Randomization is created by using an electronic randomizer. Upon consent, the patient's assignment (per the randomizer) will be submitted to the Investigational Drug Service (IDS) Pharmacy by a department employee with no direct patient interaction.

Keywords

Intestinal Disease, Laparoscopic Bowel Resection, Sugammadex, Neostigmine, Glycopyrrolate, GI-2, Intestinal Diseases, Neostigmine Injectable Solution, Sugammadex injection, Neostigmine plus Glycopyrrolate

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age 18 or older
  • Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission

You CAN'T join if...

  • 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

Location

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Robert R Field, MD
    Health Sciences Professor, Anesthesiology and Perioperative Care, School of Medicine. Authored (or co-authored) 5 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06112353
Phase
Phase 4 Intestinal Disease Research Study
Study Type
Interventional
Participants
Expecting 128 study participants
Last Updated