Fentanyl vs. Remifentanil in Laparoscopic Cholecystectomy: Effects on Bowel Function and Pain

Konya City Hospital

Status: Enrolling

Conditions: Postoperative Pain; Postoperative Bowel Function

Treatments: Drug: Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia; Drug: Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07182097

364/2025

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for elective laparoscopic cholecystectomy
• Provided written informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups

Fentanyl Group

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia

Remifentanil Group

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia