Postoperative Bowel FunctionNCT07182097
Fentanyl vs. Remifentanil in Laparoscopic Cholecystectomy: Effects on Bowel Function and Pain
A study testing Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia and Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia in people with Postoperative Bowel Function and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Bowel Function, Postoperative Pain
- What is being tested?
- Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia and Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
- Provided written informed consent
Who cannot join
- Opioid use preoperatively
- Previous abdominal surgery
- History of ileus or gastrointestinal disease
- Preoperative electrolyte imbalance
- Liver or renal failure
- Neuromuscular or psychiatric disorders
Show all 9Show fewer
- Known allergy to study medications
- Emergency surgery
- Surgical duration exceeding 90 minutes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Karatay, Konya, 42050
MUSTAFA BÜYÜKCAVLAK, MD, 05064733392, mustafabcavlak@gmail.com
About this study
Official title: Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- 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
- Keywords
- postoperative pain, postoperative ileus, postoperative bowel function, fentanyl, remifentanil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesiaDrug
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.
Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours.
Measured: Up to 72 hours postoperatively
Secondary outcomes (4)
Time to first defecation
Time from postoperative care unit admission to first defecation, recorded in hours.
Measured: Up to 72 hours postoperatively
Postoperative pain scores (NRS)
Pain intensity assessed using Numeric Rating Scale (0-10) at 0, 2, 4, 6, 12, and 24 hours after surgery.
Measured: First 24 hours postoperatively
Incidence of prolonged postoperative ileus
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.
Measured: Within 7 days postoperatively
Rescue analgesic consumption
Total amount of tramadol administered for NRS ≥4.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start19 Sep 2025
- Primary completion27 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Bowel FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSTAFA BÜYÜKCAVLAK, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182097
- Sponsor's protocol ID
- 364/2025
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31592999de 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.
PubMed 29739538Muller-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.
PubMed 28034973Vather 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.
PubMed 23377782
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Fentanyl vs. Remifentanil on Postoperative Bowel Function and Pain Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07182097
- Acronym / sponsor ID
- 364/2025
- Conditions
- Postoperative Bowel Function, Postoperative Pain
- Keywords
- postoperative pain, postoperative ileus, postoperative bowel function, fentanyl, remifentanil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 27 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Group | Active comparator | Drug: Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesiaPatients 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. |
| Remifentanil Group | Active comparator | Drug: Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesiaPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
- Provided written informed consent
Key exclusion criteria (9 listed)
- Opioid use preoperatively
- Previous abdominal surgery
- History of ileus or gastrointestinal disease
- Preoperative electrolyte imbalance
- Liver or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesiaPatients 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 Group |
| Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesiaPatients 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 Group |
Primary outcome
Time to first flatus
Time frame: Up to 72 hours postoperatively
Time from admission to the post-anesthesia care unit (PACU) until the first passage of flatus, recorded in hours.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 31592999Niedermayer 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.
- Background: PubMed 29739538de 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.
- Background: PubMed 28034973Muller-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.
- Background: PubMed 23377782Vather 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl 2 µg/kg IV bolus + 1-2 µg/kg/h infusion during anesthesia and Remifentanil 1 µg/kg IV bolus + 0.1-1 µg/kg/min infusion during anesthesia in people with Postoperative Bowel Function and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUSTAFA BÜYÜKCAVLAK, MD (+905064733392, mustafabcavlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus (time frame: Up to 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07182097, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.