Fentanyl vs. Remifentanil in Laparoscopic Cholecystectomy: Effects on Bowel Function and Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia, Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia.
- Who it may be relevant to
- Registry conditions: Postoperative Bowel Function, Postoperative Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia
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. - Drug Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia
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 outcome measures
- Time to first flatus [Time frame: Up to 72 hours postoperatively]
Secondary outcome measures (4)
- Time to first defecation [Time frame: Up to 72 hours postoperatively]
- Postoperative pain scores (NRS) [Time frame: First 24 hours postoperatively]
- Incidence of prolonged postoperative ileus [Time frame: Within 7 days postoperatively]
- Rescue analgesic consumption [Time frame: First 24 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Konya City Hospital — Karatay
Publications
- Niedermayer S, Heyn J, Guenther F, Kuchenhoff H, Luchting B. Remifentanil for abdominal surgery is associated with unexpectedly unfavorable outcomes. Pain. 2020 Feb;161(2):266-273. doi: 10.1097/j.pain.0000000000001713. PMID 31592999
- de Boer HD, Detriche O, Forget P. Opioid-related side effects: Postoperative ileus, urinary retention, nausea and vomiting, and shivering. A review of the literature. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):499-504. doi: 10.1016/j.bpa.2017.07.002. Epub 2017 Jul 8. PMID 29739538
- Muller-Lissner S, Bassotti G, Coffin B, Drewes AM, Breivik H, Eisenberg E, Emmanuel A, Laroche F, Meissner W, Morlion B. Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline. Pain Med. 2017 Oct 1;18(10):1837-1863. doi: 10.1093/pm/pnw255. PMID 28034973
- Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg. 2013 May;17(5):962-72. doi: 10.1007/s11605-013-2148-y. Epub 2013 Feb 2. PMID 23377782
Identifiers
NCT: NCT07182097 · 364/2025