Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

NCT ID: NCT06112353

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2026-07-31

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

Detailed 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.

Conditions

Intestinal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neostigmine plus Glycopyrrolate

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

Group Type: ACTIVE_COMPARATOR

Neostigmine Injectable Solution

Intervention Type: DRUG

Examine GI-2 recovery

Sugammadex

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)

Group Type: ACTIVE_COMPARATOR

Sugammadex injection

Intervention Type: DRUG

Examine GI-2 recovery

Interventions

Neostigmine Injectable Solution

Examine GI-2 recovery

Intervention Type: DRUG

Sugammadex injection

Examine GI-2 recovery

Intervention Type: DRUG

Other Intervention Names

Neostigmine plus Glycopyrrolate; Group B; Sugammadex; Group A

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Robert Ryan Field

Associate Clinical Professor, Dept of Anesthesiology & Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert R Field, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Clinical Professor

Locations

UC Irvine Medical Center

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paulette Mensah, BA

Role: CONTACT

pmensah@hs.uci.edu

714-456-8818

Robert R Field, MD

Role: CONTACT

fieldr@hs.uci.edu

714-506-5703

Facility Contacts

David Whaley, MS

Role: primary

whaleyd@hs.uci.edu

714.456.5501

References

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.

Reference Type: BACKGROUND

PMID: 28806470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28381944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32099426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33039637 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33534892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19015469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34986061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19222430 (View on PubMed)

Other Identifiers

Field 100931

Identifier Type: OTHER

Identifier Source: secondary_id

2295

Identifier Type: -

Identifier Source: org_study_id