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Идёт набор NCT07182097

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

Без фазы С лечением Postoperative Bowel Function Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Postoperative Bowel Function, Postoperative Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Обзор

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.

Вмешательства

  • Препарат 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.
  • Препарат 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.

Первичные конечные точки

  • Time to first flatus [Срок оценки: Up to 72 hours postoperatively]
Вторичные конечные точки (4)
  • Time to first defecation [Срок оценки: Up to 72 hours postoperatively]
  • Postoperative pain scores (NRS) [Срок оценки: First 24 hours postoperatively]
  • Incidence of prolonged postoperative ileus [Срок оценки: Within 7 days postoperatively]
  • Rescue analgesic consumption [Срок оценки: First 24 hours postoperatively]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Konya City Hospital — Karatay

Публикации

  • 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

Идентификаторы

NCT: NCT07182097 · 364/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗