Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures (NCT07649746) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
80 participantsStarted 2026-06
Plain-language summary
This study will compare two different sedation approaches used during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). One group will receive dexmedetomidine alone (opioid-free sedation), while the other group will receive dexmedetomidine combined with remifentanil (opioid-based sedation).
The purpose of the study is to determine whether an opioid-free sedation approach can reduce opioid-related adverse symptoms, such as nausea, vomiting, dizziness, drowsiness, dry mouth, headache, and fatigue. The study will also evaluate quality of recovery, patient and healthcare staff satisfaction, hemodynamic effects, complications, and time to discharge after the procedure.
Who can participate
Age range
18 Years – 85 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:
* Age 18 to 85 years
* ASA physical status I-III
* Scheduled for ERCP, gastroscopy, or colonoscopy
Exclusion Criteria:
* Refusal to participate in the study
* Inability to communicate
* Alcohol or substance abuse
* Neuropsychiatric disease
* Severe respiratory failure
* Severe heart failure
* Pregnancy
* Body mass index (BMI) \>30 kg/m²
* Hearing impairment
* History of allergy to study medications
* Requirement for orotracheal intubation or general anesthesia
* Procedures lasting less than 20 minutes
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
Incidence of Opioid-Related Adverse Symptoms
Timeframe: Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours
Trial details
NCT IDNCT07649746
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital