Postoperative Bowel Function, Postoperative Pain
Conditions
Keywords
postoperative pain, postoperative ileus, postoperative bowel function, fentanyl, remifentanil
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.
Interventions
DRUGFentanyl 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.
DRUGRemifentanil 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.
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first flatus | Up to 72 hours postoperatively | Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first defecation | Up to 72 hours postoperatively | Time from postoperative care unit admission to first defecation, recorded in hours. |
| Postoperative pain scores (NRS) | First 24 hours postoperatively | Pain intensity assessed using Numeric Rating Scale (0-10) at 0, 2, 4, 6, 12, and 24 hours after surgery. |
| Incidence of prolonged postoperative ileus | 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. |
| Rescue analgesic consumption | First 24 hours postoperatively | Total amount of tramadol administered for NRS ≥4. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMUSTAFA BÜYÜKCAVLAK, MD
Outcome results
None listed