Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

NCT06112353 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2295Field 100931
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intestinal Disease

Keywords

Laparoscopic Bowel Resection; Sugammadex; Neostigmine; Glycopyrrolate; GI-2

Outcome Measures

Primary Outcomes (1)

• GI-2 Recovery

  GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet

  Post-surgically until report of first bowel movement

Secondary Outcomes (8)

• Cost of Stay

  From hospital admission to discharge

• Length of Stay

  From hospital admission to discharge

• Morbidity & Mortality

  Up to 30 days post surgery

• Post Reversal Bradycardia

  Post surgically but prior to PACU discharge, up to 24 hours

• Duration of PACU Stay

  From surgical end time to PACU discharge, up to 24 hours

Study Arms (2)

Neostigmine plus Glycopyrrolate

ACTIVE COMPARATOR

0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 1. Syringe #1: Glycopyrrolate 2. Syringe #2: Neostigmine

Drug: Neostigmine Injectable Solution

Sugammadex

ACTIVE COMPARATOR

2.0 mg/kg of Sugammadex plus saline equivalent 2 syringes numbered 1 and 2 1. Syringe #1: 0.9% sodium chloride 2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)

Drug: Sugammadex injection

Interventions

Sugammadex injection DRUG

Examine GI-2 recovery

Also known as: Sugammadex, Group A

Sugammadex

Neostigmine Injectable Solution DRUG

Examine GI-2 recovery

Also known as: Neostigmine plus Glycopyrrolate, Group B

Neostigmine plus Glycopyrrolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (8)

• Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.

  PMID: 28806470 BACKGROUND

• Briggs A, Goldberg J. Tips, Tricks, and Technique for Laparoscopic Colectomy. Clin Colon Rectal Surg. 2017 Apr;30(2):130-135. doi: 10.1055/s-0036-1597313.

  PMID: 28381944 BACKGROUND

• Deyhim N, Beck A, Balk J, Liebl MG. Impact of Sugammadex Versus Neostigmine/Glycopyrrolate on Perioperative Efficiency. Clinicoecon Outcomes Res. 2020 Jan 31;12:69-79. doi: 10.2147/CEOR.S221308. eCollection 2020.

  PMID: 32099426 BACKGROUND

• Gray PJ, Goldwag JL, Eid MA, Sacks OA, Wilson LR, Wilson MZ, Ivatury SJ. Does Bowel Function Change After Colectomy for Colon Malignancy? J Surg Res. 2021 Feb;258:283-288. doi: 10.1016/j.jss.2020.09.003. Epub 2020 Oct 8.

  PMID: 33039637 BACKGROUND

• Bhurwal A, Minacapelli CD, Patel A, Mutneja H, Goel A, Shah I, Bansal V, Brahmbhatt B, Das KM. Evaluation of a U.S. National Cohort to Determine Utilization in Colectomy Rates for Ulcerative Colitis Among Ethnicities. Inflamm Bowel Dis. 2022 Jan 5;28(1):54-61. doi: 10.1093/ibd/izab020.

  PMID: 33534892 BACKGROUND

• Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.

  PMID: 19015469 BACKGROUND

• Deljou A, Soleimani J, Sprung J, Schroeder DR, Weingarten TN. Effects of Reversal Technique for Neuromuscular Paralysis on Time to Recovery of Bowel Function after Craniotomy. Am Surg. 2023 May;89(5):1605-1609. doi: 10.1177/00031348211058631. Epub 2022 Jan 5.

  PMID: 34986061 BACKGROUND

• Booij LH, van Egmond J, Driessen JJ, de Boer HD. In vivo animal studies with sugammadex. Anaesthesia. 2009 Mar;64 Suppl 1:38-44. doi: 10.1111/j.1365-2044.2008.05869.x.

  PMID: 19222430 BACKGROUND

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Limitations and Caveats

This was a single-center study, which may limit the generalizability of the findings. Administration of open-label rescue reversal medication, when clinically indicated, may have influenced the interpretation of postoperative outcomes. The study should be interpreted in the context of these design considerations.

Results Point of Contact

• Title: Robert Ryan Field, MD
• Organization: University of California, Irvine

fieldr@hs.uci.edu

7144565501

Study Officials

• Robert R Field, MD

  Associate Clinical Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Dept of Anesthesiology & Perioperative Medicine

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: April 17, 2024
• Primary Completion: March 4, 2026
• Study Completion: June 30, 2026
• Last Updated: August 25, 2026
• Results First Posted: August 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)