ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Current monitoring often relies only on SpO₂, while capnography and the Integrated Pulmonary Index (IPI) provide earlier detection of respiratory events but are underused in ERCP studies.
This study compares dexmedetomidine and propofol in high-risk ERCP patients, focusing on respiratory and hemodynamic effects, propofol consumption, recovery, and discharge times. The hypothesis is that dexmedetomidine will cause fewer adverse respiratory and hemodynamic effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients over 18 years of age
* ASA physical status III-IV
* scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital
Exclusion Criteria:
* pregnant women;
* patients with neuropsychiatric disease,
* substance abuse, or known allergy to the sedatives used;
* patients with baseline heart rate ≤50 bpm;
* those who did not provide consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
heart rate
Timeframe: during the endoscopy (30-60 minute)
2
arterial blood pressure
Timeframe: during the endoscopy (30-60 minute)
3
oxygen saturation
Timeframe: during the endoscopy (30-60 minute)
4
end-tidal CO₂
Timeframe: during the endoscopy (30-60 minute)
Trial details
NCT IDNCT07166614
SponsorSisli Hamidiye Etfal Training and Research Hospital