NCT07182097 Fentanyl vs. Remifentanil in Laparoscopic Cholecystectomy: Effects on Bowel Function and Pain
| NCT ID | NCT07182097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Konya City Hospital |
| Condition | Postoperative Bowel Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2026-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-09-19 with a primary completion date of 2026-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07182097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Postoperative Bowel Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07182097 currently recruiting?
Yes, NCT07182097 is actively recruiting participants. Contact the research team at mustafabcavlak@gmail.com for enrollment information.
Where is the NCT07182097 trial being conducted?
This trial is being conducted at Karatay, Turkey (Türkiye).
Who is sponsoring the NCT07182097 clinical trial?
NCT07182097 is sponsored by Konya City Hospital. The trial plans to enroll 106 participants.