NCT06112353

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
3mo left

Started Apr 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Jul 2026

First Submitted

Initial submission to the registry

October 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 23, 2026

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

October 20, 2023

Last Update Submit

January 21, 2026

Conditions

Intestinal Disease

Keywords

Laparoscopic Bowel ResectionSugammadexNeostigmineGlycopyrrolateGI-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

    Up to 24 hours post surgery

Secondary Outcomes (9)

  • Cost of Stay

    From hospital admission to discharge, up to 30 days

  • Length of Stay

    From hospital admission to discharge, up to 60 days

  • Morbidity & Mortality Rate

    30 days post surgery

  • Number of Participants Experiencing 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

  • +4 more secondary outcomes

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 injectionDRUG

Examine GI-2 recovery

Also known as: Sugammadex, Group A
Sugammadex
Neostigmine Injectable SolutionDRUG

Examine GI-2 recovery

Also known as: Neostigmine plus Glycopyrrolate, Group B
Neostigmine plus Glycopyrrolate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

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: 28806470BACKGROUND

  • 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: 28381944BACKGROUND

  • 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: 32099426BACKGROUND

  • 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: 33039637BACKGROUND

  • 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: 33534892BACKGROUND

  • 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: 19015469BACKGROUND

  • 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: 34986061BACKGROUND

  • 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: 19222430BACKGROUND

MeSH Terms

Conditions

Intestinal Diseases

Interventions

NeostigmineGlycopyrrolateSugammadex

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Robert R Field, MD

    Associate Clinical Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Whaley

CONTACT

714-456-5501whaleyd@hs.uci.edu

Robert R Field, MD

CONTACT

714-506-5703fieldr@hs.uci.edu

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 (Estimated)

July 1, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 23, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)