Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Intestinal Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112353
• Other study ID #: 2295
• Secondary ID: Field 100931
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of California, Irvine
• Contact: Paulette Mensah, BA
• Phone: 714-456-8818
• Email: pmensah[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Disease
• Intestinal Diseases

Intervention

Drug:
• Neostigmine Injectable Solution
Examine GI-2 recovery
• Sugammadex injection
Examine GI-2 recovery

Locations

Country	Name	City	State
United States	UC Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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