Clinical trial NCT06112353: Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intestinal Disease
Keywords: Laparoscopic Bowel Resection
Sugammadex
Neostigmine
Glycopyrrolate
GI-2
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-11-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: GI-2 Recovery
timeFrame: Up to 24 hours post surgery
Secondary outcomes:
measure: Cost of Stay
timeFrame: From hospital admission to discharge, up to 30 days
measure: Length of Stay
timeFrame: From hospital admission to discharge, up to 60 days
measure: Morbidity & Mortality Rate
timeFrame: 30 days post surgery
measure: Number of Participants Experiencing Post Reversal Bradycardia
timeFrame: Post surgically but prior to PACU discharge, up to 24 hours
measure: Duration of PACU Stay
timeFrame: From surgical end time to PACU discharge, up to 24 hours
measure: Time to Out of Bed
timeFrame: Up to 24 hours post surgery
measure: Amount of Fluid Administration
timeFrame: Intraoperative
measure: Presence of Bowel Adhesion
timeFrame: Intraoperative
measure: Number of Participants Experiencing PONV
timeFrame: Postoperative to discharge, up to 1 week
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
affiliation: Associate Clinical Professor
name: Robert R Field, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.