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

NCT07182097 | Recruiting

• 1 other identifier: 364/2025
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Bowel Function; Postoperative Pain

Keywords

postoperative pain; postoperative ileus; postoperative bowel function; fentanyl; remifentanil

Outcome Measures

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.

  Up to 72 hours postoperatively

Secondary Outcomes (4)

• Time to first defecation

  Up to 72 hours postoperatively

• Postoperative pain scores (NRS)

  First 24 hours postoperatively

• Incidence of prolonged postoperative ileus

  Within 7 days postoperatively

• Rescue analgesic consumption

  First 24 hours postoperatively

Study Arms (2)

Fentanyl Group

ACTIVE COMPARATOR

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

Remifentanil Group

ACTIVE COMPARATOR

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.

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

Interventions

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.

Fentanyl Group

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.

Remifentanil Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for elective laparoscopic cholecystectomy
• Provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Karatay, Konya, 42050, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

MUSTAFA BÜYÜKCAVLAK, MD

CONTACT

+905064733392; mustafabcavlak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: September 19, 2025
• Primary Completion: April 27, 2026
• Study Completion: April 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)