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Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Recruiting
18 years and older
All
Phase 4

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Overview

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

Description

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.

Eligibility

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

Study details
    Intestinal Disease

NCT06112353

University of California, Irvine

15 October 2025

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