Konya City Hospital
Karatay, Konya, 42050, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07182097
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Karatay, Konya, 42050, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Up to 72 hours postoperatively
Time from postoperative care unit admission to first defecation, recorded in hours.
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.
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.
Time frame: First 24 hours postoperatively
Total amount of tramadol administered for NRS ≥4.
Contact information is provided by the study sponsor or research team.
Konya City Hospital
Other
Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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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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