Neuromuscular Blockade Comparison for GI-2 Recovery After... | NCT06112353

Studies
Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

NCT06112353

Sponsor

University of California, Irvine

Status

Recruiting

Last Update Posted

Jan 23, 2026Actual

Enrollment

128Estimated

Phase

Phase 4

Conditions

Intestinal Disease

Interventions

Neostigmine Injectable Solution
Sugammadex injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Field 100931	Other Identifier	Merck Investigator Initiated Studies Program (MISP)

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2024Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Oct 20, 2023

First Submission Date that Met QC Criteria

Oct 31, 2023

First Posted Date

Nov 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Ryan Field, Associate Clinical Professor, Dept of Anesthesiology & Perioperative Medicine, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neostigmine plus Glycopyrrolate	Active Comparator	0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 Syringe #1: Glycopyrrolate 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 Syringe #1: 0.9% sodium chloride Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)	Drug: Sugammadex injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neostigmine Injectable Solution	Drug	Examine GI-2 recovery	Neostigmine plus Glycopyrrolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cost of Stay	Total cost of surgical stay	From hospital admission to discharge, up to 30 days
Length of Stay	Total time patient is at hospital

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Whaley	Contact	714-456-5501		whaleyd@hs.uci.edu
Robert R Field, MD	Contact	714-506-5703		fieldr@hs.uci.edu

Overall Officials

Name	Affiliation	Role
Robert R Field, MD	Associate Clinical Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Irvine Medical Center	Recruiting	Orange	California	92868	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28806470	Background	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.
28381944	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.

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D050338	Phenylammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals