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NCT Number: NCT07182097

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Karatay, Konya, 42050, Turkey (Türkiye)

Location status: Recruiting

Location contact

MUSTAFA BÜYÜKCAVLAK, MD

CONTACT

[email protected]

05064733392

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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.

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

Drug

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.

Primary outcomes

  1. Time to first flatus

    Time frame: Up to 72 hours postoperatively

    Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours.

Secondary outcomes

  1. Time to first defecation

    Time frame: Up to 72 hours postoperatively

    Time from postoperative care unit admission to first defecation, recorded in hours.

  2. Postoperative pain scores (NRS)

    Time frame: First 24 hours postoperatively

    Pain intensity assessed using Numeric Rating Scale (0-10) at 0, 2, 4, 6, 12, and 24 hours after surgery.

  3. Incidence of prolonged postoperative ileus

    Time frame: Within 7 days postoperatively

    Defined as persistence of ≥2 of the following for more than 3 days postoperatively: nausea/vomiting, absence of flatus for 24h, inability to tolerate oral diet for 24h, abdominal distension, radiological confirmation.

  4. Rescue analgesic consumption

    Time frame: First 24 hours postoperatively

    Total amount of tramadol administered for NRS ≥4.

Study contacts

Contact information is provided by the study sponsor or research team.

MUSTAFA BÜYÜKCAVLAK, MD

CONTACT

[email protected]

+905064733392

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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