Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery

Официальное название

Effect of Neuromuscular Reversal With Neostigmine/Atropine Versus Sugammadex on Postoperative Gastrointestinal Function Recovery Following Colorectal Surgery

Обзор

This study is a clinical research project conducted at Xijing Hospital to compare the effects of two different neuromuscular blockade reversal strategies on the recovery of gastrointestinal (GI) function after colorectal surgery. Many patients experience slow recovery of bowel function after colorectal surgery, which can lead to discomfort, nausea, vomiting, and a longer hospital stay. This study investigates whether using one medication (sugammadex) to reverse muscle relaxants used during anesthesia leads to better and faster recovery of gastrointestinal function compared to a traditional combination of medications (neostigmine with atropine). The study will include 560 adults scheduled for elective colorectal surgery. Participants will be randomly assigned to one of two groups to receive either: Sugammadex (2 mg/kg), OR Neostigmine (30 μg/kg) + Atropine (15 μg/kg) The assigned study drug will be given by intravenous injection at the end of surgery, once measurements show the muscle relaxant is starting to wear off. The patients, surgeons, outcome assessors, and statisticians will be blinded. The main goal is to see if more patients in one group recover their gastrointestinal function within 72 hours after surgery. Gastrointestinal recovery is strictly defined as both being able to tolerate food/drinks without significant nausea/vomiting AND having passed gas or had a bowel movement. The study will also compare many other important outcomes between the groups, including: 1. Time to first passage of gas, first bowel movement, and first toleration of food. 2. Pain scores and opioid pain medication use. 3. Rates of nausea and vomiting. 4. Overall quality of recovery and patient satisfaction. 5. Length of hospital stay and total hospitalization costs. 6. Occurrence of complications within 30 days after surgery. 7. The safety of both reversal strategies will be closely monitored throughout the study by recording any adverse events. This research aims to provide high-quality evidence to help anesthesiologists and surgeons choose the best method to reverse muscle relaxation, potentially leading to faster recovery, fewer complications, and a better overall experience for patients undergoing colorectal surgery.

Вмешательства

• Препарат Neostigmine + Atropine
  Participants received Neostigmine 30 μg/kg + Atropine 15 μg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.
• Препарат Sugammadex
  Participants received sugammadex 2 mg/kg after surgery once a train-of-four ratio of 0.9 and sufficient spontaneous breathing were confirmed.

Первичные конечные точки

• The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion). [Срок оценки: up to 72 hours after surgery]

Вторичные конечные точки (12)

• Time to achieve GI-3 (hours) [Срок оценки: up to 10 days after surgery]
• Time to achieve GI-2 (hours) [Срок оценки: up to 10 days after surgery]
• Incidence of Prolonged Postoperative Ileus (PPOI) [Срок оценки: 120 hours (5 days) after surgery]
• Time to first oral intake [Срок оценки: Assessed up to 10 days after surgery]
• Time to first passage of flatus [Срок оценки: Assessed up to 10 days after surgery]
• Time to first defecation [Срок оценки: Assessed up to 10 days after surgery]
• Time to first ambulation [Срок оценки: Assessed up to 10 days after surgery]
• Incidence of adverse events during the recovery period [Срок оценки: Within 2 hours after extubation]
• Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) score at 24, 48, and 72 hours after surgery [Срок оценки: At 24, 48, and 72 hours after surgery]
• Visual Analog Scale (VAS) score at rest and during activity [Срок оценки: At 24, 48, and 72 hours after surgery]
• Total opioid consumption [Срок оценки: Within 24, 48, and 72 hours after surgery]
• Postoperative Nausea and Vomiting (PONV) [Срок оценки: At 24, 48, and 72 hours after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Preoperative Mini-Mental State Examination (MMSE) score > 23
• Patients scheduled for elective colorectal surgery under general anesthesia. Disease diagnoses include colorectal cancer, benign polyps, benign strictures, or diverticular disease.
• Provide informed consent

Критерии исключения

• Presence of psychiatric disorders, cognitive impairment, or language communication barriers that may affect assessment compliance.
• Body Mass Index (BMI) ≥ 35 kg/m².
• Severe hepatic dysfunction (Child-Pugh Class C) or renal dysfunction (estimated glomerular filtration rate < 30 ml/min/1.73m² and/or receiving renal replacement therapy).
• Pre-existing severe gastrointestinal dysfunction (e.g., intestinal obstruction, active inflammatory bowel disease, severe constipation/diarrhea); receipt of neoadjuvant therapy preoperatively; planned stoma creation surgery; or scheduled for low rectal surgery (e.g., low anterior resection, abdominoperineal resection).
• History of neuromuscular disorders (e.g., myasthenia gravis) or malignant hyperthermia.
• History of opioid abuse, or chronic non-surgical pain requiring long-term analgesic therapy.
• Anticipated difficult airway, or patients planned for postoperative transfer to the intensive care unit (ICU) while intubated.
• Contraindications to the use of neostigmine, atropine, sugammadex, or rocuronium (e.g., known drug allergy, epilepsy, unstable angina, asthma, glaucoma, uncontrolled malignant arrhythmias especially atrioventricular block, severe cardiac valve stenosis); or current use of medications that may significantly influence the effects of neuromuscular blocking agents (e.g., antibiotics such as tetracyclines, aminoglycosides, polymyxins, and clindamycin; antiepileptic drugs; lithium; certain antidepressants such as sertraline and amitriptyline).
• Pregnant or lactating women.
• Current participation in other clinical trials that may interfere with the results of this study.

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

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07271875 · KY20252236

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗