Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Neostigmine Injectable Solution
  Examine GI-2 recovery
• Препарат Sugammadex injection
  Examine GI-2 recovery

Первичные конечные точки

• GI-2 Recovery [Срок оценки: Up to 24 hours post surgery]

Вторичные конечные точки (9)

• Cost of Stay [Срок оценки: From hospital admission to discharge, up to 30 days]
• Length of Stay [Срок оценки: From hospital admission to discharge, up to 60 days]
• Morbidity & Mortality Rate [Срок оценки: 30 days post surgery]
• Number of Participants Experiencing Post Reversal Bradycardia [Срок оценки: Post surgically but prior to PACU discharge, up to 24 hours]
• Duration of PACU Stay [Срок оценки: From surgical end time to PACU discharge, up to 24 hours]
• Time to Out of Bed [Срок оценки: Up to 24 hours post surgery]
• Amount of Fluid Administration [Срок оценки: Intraoperative]
• Presence of Bowel Adhesion [Срок оценки: Intraoperative]
• Number of Participants Experiencing PONV [Срок оценки: Postoperative to discharge, up to 1 week]

Критерии участия

Критерии включения

• Age 18 or older
• Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UC Irvine Medical Center — Orange

Публикации

• 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. PMID 28806470
• 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. PMID 28381944
• 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. PMID 32099426
• 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. PMID 33039637
• 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. PMID 33534892
• 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. PMID 19015469
• 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. PMID 34986061
• 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. PMID 19222430

Идентификаторы

NCT: NCT06112353 · 2295 · Field 100931

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗