Effect of Neuromuscular Reversal With Neostigmine/Atropine Versus Sugammadex on Postoperative Gastrointestinal Function Recovery Following Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 560
- 主要终点
- The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion).
研究概览
简要总结
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:
- Time to first passage of gas, first bowel movement, and first toleration of food.
- Pain scores and opioid pain medication use.
- Rates of nausea and vomiting.
- Overall quality of recovery and patient satisfaction.
- Length of hospital stay and total hospitalization costs.
- Occurrence of complications within 30 days after surgery.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Statisticians are also masked
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sugammadex group
Sugammadex 2 mg/kg administered after surgery
干预措施: Sugammadex (Drug)
Neostigmine group
Neostigmine 30 μg/kg + Atropine 15 μg/kg administered after surgery
干预措施: Neostigmine + Atropine (Drug)
结局指标
主要结局
The proportion of patients recovering gastrointestinal function within 72 hours after surgery (assessed using the GI-3 criterion).
时间窗: up to 72 hours after surgery
GI-3 is defined as the ability to tolerate oral intake (no significant nausea or vomiting during three consecutive meals of solid food and beverages) and the passage of flatus or stool (whichever occurs first).
次要结局
- Time to achieve GI-3 (hours)(up to 10 days after surgery)
- Time to achieve GI-2 (hours)(up to 10 days after surgery)
- Time to first passage of flatus(Assessed up to 10 days after surgery)
- Incidence of Prolonged Postoperative Ileus (PPOI)(120 hours (5 days) after surgery)
- Time to first oral intake(Assessed up to 10 days after surgery)
- Time to first defecation(Assessed up to 10 days after surgery)
- Time to first ambulation(Assessed up to 10 days after surgery)
- Incidence of adverse events during the recovery period(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(At 24, 48, and 72 hours after surgery)
- Patient-assessed time to readiness for discharge (days)(Assessed up to 30 days after surgery)
- Visual Analog Scale (VAS) score at rest and during activity(At 24, 48, and 72 hours after surgery)
- Postoperative Quality of Recovery(From postoperative day 1 to day 7 (or until discharge, whichever comes first))
- Time to meet medically defined discharge criteria (days)(Assessed up to 30 days after surgery)
- Days Alive and Out of Hospital within 30 days after surgery (DAOH30)(Within 30 days after surgery)
- Adverse events (AEs)(From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery))
- Total opioid consumption(Within 24, 48, and 72 hours after surgery)
- Incidence of complications(Within 30 days after surgery)
- Postoperative Nausea and Vomiting (PONV)(At 24, 48, and 72 hours after surgery)
- Incidence of postoperative delirium(Within 7 days after surgery (or until discharge, whichever comes first))
- Quality of life assessment using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire(Preoperatively, postoperative day 7, and postoperative day 30)
- Postoperative length of hospital stay(From postoperative Day 1 to hospital discharge, assessed up to postoperative 30 days)
- Total hospitalization costs(From hospital admission to hospital discharge, assessed up to postoperative 30 days)
研究者
Chong Lei, MD & phD
Professor. MD &phD
Xijing Hospital