Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

March 28, 2024 updated by: Robert Ryan Field, University of California, Irvine

Sugammadex VS Neostigmine and Glycopyrrolate Reversal of Neuromuscular Relaxation For Time to Return of Bowel Function After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial For Quality Improvement

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
        • Contact:
        • Principal Investigator:
          • Robert R Field, MD
        • Sub-Investigator:
          • Joseph C Carmichael, MD
        • Sub-Investigator:
          • Steven D Mills, MD
        • Sub-Investigator:
          • Skandan Shanmugan, MD
        • Sub-Investigator:
          • Valery C ilchez, MD
        • Sub-Investigator:
          • Matthew D Whealon, MD
        • Sub-Investigator:
          • Paulette Mensah, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Neostigmine Injectable Solution
Examine GI-2 recovery
Other Names:
  • Group B
  • Neostigmine plus Glycopyrrolate
Active Comparator: 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)
Drug: Sugammadex injection
Examine GI-2 recovery
Other Names:
  • Group A
  • Sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GI-2 Recovery
Time Frame: Up to 24 hours post surgery
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
Up to 24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of Stay
Time Frame: From hospital admission to discharge, up to 30 days
Total cost of surgical stay
From hospital admission to discharge, up to 30 days
Length of Stay
Time Frame: From hospital admission to discharge, up to 60 days
Total time patient is at hospital
From hospital admission to discharge, up to 60 days
Morbidity & Mortality Rate
Time Frame: 30 days post surgery
Symptomatic disease presence and death
30 days post surgery
Number of Participants Experiencing Post Reversal Bradycardia
Time Frame: Post surgically but prior to PACU discharge, up to 24 hours
Slowed heart rate following reversal
Post surgically but prior to PACU discharge, up to 24 hours
Duration of PACU Stay
Time Frame: From surgical end time to PACU discharge, up to 24 hours
Time in PACU, not owing to bed availability
From surgical end time to PACU discharge, up to 24 hours
Time to Out of Bed
Time Frame: Up to 24 hours post surgery
Time for patient to be able to get out of bed and walk post surgically
Up to 24 hours post surgery
Amount of Fluid Administration
Time Frame: Intraoperative
IV fluid administration during surgery
Intraoperative
Presence of Bowel Adhesion
Time Frame: Intraoperative
Scar tissue found in bowels
Intraoperative
Number of Participants Experiencing PONV
Time Frame: Postoperative to discharge, up to 1 week
Post operative nausea and vomiting
Postoperative to discharge, up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Robert R Field, MD, Associate Clinical Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2295
  • Field 100931 (Other Identifier: Merck Investigator Initiated Studies Program (MISP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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