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OpenTrials
Completed

NCT Number: NCT06112353

Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine Injectable Solution

Drug

Examine GI-2 recovery

Other names: Neostigmine plus Glycopyrrolate, Group B

Sugammadex injection

Drug

Examine GI-2 recovery

Other names: Sugammadex, Group A

Primary outcomes

  1. GI-2 Recovery

    Time frame: Post-surgically until report of first bowel movement

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

Secondary outcomes

  1. Cost of Stay

    Time frame: From hospital admission to discharge

    Total cost of surgical stay

  2. Length of Stay

    Time frame: From hospital admission to discharge

    Total time patient is at hospital

  3. Morbidity & Mortality

    Time frame: Up to 30 days post surgery

    Morbidity was defined as the number of participants with at least one predefined postoperative complication, including postoperative ileus, pulmonary complications, cardiovascular complications, surgical site infection, urinary tract infection, acute kidney injury, thromboembolic events, reoperation, anastomotic leak, wound dehiscence, or postoperative transfusion within 30 days after surgery. Mortality was defined as all-cause death occurring within 30 days after surgery. Complications were identified through review of the electronic medical record.

  4. Post Reversal Bradycardia

    Time frame: Post surgically but prior to PACU discharge, up to 24 hours

    Number of participants experiencing post-reversal bradycardia prior to discharge from PACU

  5. 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. Defined as time to achieve a sustained Aldrete score ≥8.

  6. 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

  7. Amount of Fluid Administration

    Time frame: Intraoperative and postoperative including PACU stay, up to 24 hours

    Total amount of IV fluids administered during and after surgery through PACU stay.

  8. Postoperative Nausea and Vomiting

    Time frame: Postoperative to discharge, up to 1 week

    Number of Participants Experiencing PONV

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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