Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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 Syringe #1: Glycopyrrolate Syringe #2: Neostigmine |
Drug: Neostigmine Injectable Solution
Examine GI-2 recovery
Other Names:
|
| Active Comparator: Sugammadex 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
Examine GI-2 recovery
Other Names:
|
Outcome Measures
Primary Outcome Measures
- GI-2 Recovery [Up to 24 hours post surgery]
GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet
Secondary Outcome Measures
- Cost of Stay [From hospital admission to discharge, up to 30 days]
Total cost of surgical stay
- Length of Stay [From hospital admission to discharge, up to 60 days]
Total time patient is at hospital
- Morbidity & Mortality Rate [30 days post surgery]
Symptomatic disease presence and death
- Number of Participants Experiencing Post Reversal Bradycardia [Post surgically but prior to PACU discharge, up to 24 hours]
Slowed heart rate following reversal
- Duration of PACU Stay [From surgical end time to PACU discharge, up to 24 hours]
Time in PACU, not owing to bed availability
- Time to Out of Bed [Up to 24 hours post surgery]
Time for patient to be able to get out of bed and walk post surgically
- Amount of Fluid Administration [Intraoperative]
IV fluid administration during surgery
- Presence of Bowel Adhesion [Intraoperative]
Scar tissue found in bowels
- Number of Participants Experiencing PONV [Postoperative to discharge, up to 1 week]
Post operative nausea and vomiting
Eligibility Criteria
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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC Irvine Medical Center | Orange | California | United States | 92868 |
Sponsors and Collaborators
- University of California, Irvine
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Robert R Field, MD, Associate Clinical Professor
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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