Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Time to first flatus
研究概览
简要总结
Background: Postoperative ileus (POI) is a common complication after abdominal surgery, leading to delayed gastrointestinal recovery, prolonged hospitalization, and increased healthcare costs. Opioids, while essential for intraoperative analgesia, are known to impair bowel motility through their μ-receptor effects. Among opioids, fentanyl and remifentanil are widely used but differ in their pharmacokinetic and pharmacodynamic profiles. Remifentanil undergoes rapid metabolism, resulting in a shorter context-sensitive half-life, while fentanyl accumulates with longer infusions. Although remifentanil may theoretically have less impact on bowel recovery, its potential to induce opioid-induced hyperalgesia (OIH) and increased analgesic requirements might prolong gastrointestinal dysfunction and worsen postoperative pain outcomes.
Objective: This randomized controlled trial aims to compare the effects of intraoperative fentanyl versus remifentanil on the recovery of postoperative bowel function and pain outcomes in patients undergoing elective laparoscopic cholecystectomy.
Methods: A total of 106 patients, aged 18-65 years and classified as ASA I-II, will be randomized into two groups: Group F (fentanyl) and Group R (remifentanil). Standardized anesthesia with propofol, rocuronium, and sevoflurane will be applied. The primary endpoint is time to first flatus. Secondary endpoints include time to first defecation, tolerance of oral diet, incidence of prolonged POI, postoperative pain scores, analgesic consumption, PONV incidence, PACU and hospital length of stay, and patient satisfaction.
Significance: The findings of this study will provide clinical evidence on whether fentanyl or remifentanil is more advantageous in terms of gastrointestinal recovery and pain management following laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Scheduled for elective laparoscopic cholecystectomy
- •Provided written informed consent
排除标准
- •Opioid use preoperatively
- •Previous abdominal surgery
- •History of ileus or gastrointestinal disease
- •Preoperative electrolyte imbalance
- •Liver or renal failure
- •Neuromuscular or psychiatric disorders
- •Known allergy to study medications
- •Emergency surgery
- •Surgical duration exceeding 90 minutes
研究组 & 干预措施
Remifentanil Group
Patients will receive remifentanil 1 µg/kg IV bolus at induction, followed by a continuous infusion of 0.1-1 µg/kg/min during maintenance of anesthesia. Standard anesthesia will be provided with propofol, rocuronium, and sevoflurane.
干预措施: Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia (Drug)
Fentanyl Group
Patients will receive fentanyl 2 µg/kg IV bolus at induction, followed by a continuous infusion of 1-2 µg/kg/h during maintenance of anesthesia. Standard anesthesia will be provided with propofol, rocuronium, and sevoflurane.
干预措施: Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia (Drug)
结局指标
主要结局
Time to first flatus
时间窗: Up to 72 hours postoperatively
Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours.
次要结局
- Rescue analgesic consumption(First 24 hours postoperatively)
- Time to first defecation(Up to 72 hours postoperatively)
- Postoperative pain scores (NRS)(First 24 hours postoperatively)
- Incidence of prolonged postoperative ileus(Within 7 days postoperatively)
研究者
MUSTAFA BÜYÜKCAVLAK
Specialist in Anesthesiology and Intensive Care
Konya City Hospital