Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP (NCT07204106) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP
China180 participantsStarted 2025-10-02
Plain-language summary
This prospective randomized single-blind study evaluated the safety and efficacy of combining dexmedetomidine nasal spray with propofol for ERCP (Endoscopic Retrograde Cholangiopancreatography) sedation in eligible patients aged 18-70 years undergoing elective procedures. The primary objectives were to determine: 1) whether this regimen reduced intraoperative hypoxemia (decreased blood oxygen levels), decreased propofol dosage, and improved postoperative recovery quality; 2) to assess nasal administration safety and identify potential medical issues (e.g., abnormal blood pressure or bradycardia) compared to intravenous injection and control group protocols. Participants were randomly assigned to three groups: ① nasal spray group (preoperative nasal spray of dexmedetomidine + propofol), ② intravenous group (preoperative intravenous injection of dexmedetomidine + propofol), ③ and conventional group (propofol alone).
Who can participate
Age range
18 Years – 70 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:
* no restriction on gender,
* aged 18-70 years,
* BMI of 18-30 kg/m²,
* American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ.
Exclusion Criteria:
* Patients who explicitly refused to participate in the study;
* Patients with difficult airway management (modified Mallampati score of Grade IV);
* Patients with anemia or thrombocytopenia (Hb \< 90 g/L, PLT \< 80×10⁹/L);
* Patients with abnormal liver or kidney function;
* Patients with a history of nasal surgery/trauma or deviated nasal septum;
* Patients with allergies or contraindications to dexmedetomidine, opioids, propofol, rocuronium, or their components;
* Patients with a history of abnormal recovery from previous surgery or anesthesia.
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 intraoperative hypoxemia
Timeframe: From the start of the surgery to 1 hour after the surgery