Fentanyl vs. Remifentanil in Laparoscopic Cholecystectomy: Effects on Bowel Function and Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKonya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years
American Society of Anesthesiologists (ASA) physical status I or II
Scheduled for elective laparoscopic cholecystectomy
Provided written informed consent
Disqualifiers
Opioid use preoperatively
Previous abdominal surgery
History of ileus or gastrointestinal disease
Preoperative electrolyte imbalance
Trial design
Design model
Parallel
Treatments tested in this trial
Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia
DrugPatients 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
DrugPatients 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 groups
106 Participants
are divided into 2 treatment groupsGroup A: Fentanyl GroupActive comparator 1 intervention
Group B: Remifentanil GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first flatus
Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours.
Time frame
Up to 72 hours postoperativelySecondary outcomes
1
Time to first defecation
Time from postoperative care unit admission to first defecation, recorded in hours.
Time frame
Up to 72 hours postoperatively2
Postoperative pain scores (NRS)
Pain intensity assessed using Numeric Rating Scale (0-10) at 0, 2, 4, 6, 12, and 24 hours after surgery.
Time frame
First 24 hours postoperatively3
Incidence of prolonged postoperative ileus
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.
Time frame
Within 7 days postoperatively4
Rescue analgesic consumption
Total amount of tramadol administered for NRS ≥4.
Time frame
First 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov