Status:
COMPLETED
Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP
Lead Sponsor:
Shiyou Wei
Collaborating Sponsors:
Shanghai East Hospital of Tongji University
Conditions:
Dexmedetomidine Induced Sedation
Nasal Administration
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This prospective randomized single-blind study evaluated the safety and efficacy of combining dexmedetomidine nasal spray with propofol for ERCP (Endoscopic Retrograde Cholangiopancreatography) sedati...
Detailed Description
General Information purpose of research：To evaluate the safety and effectiveness of right mebromide nasal spray combined with propofol in endoscopic retrograde cholangiopancreatography. Patients with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07204106
Start Date
October 2 2025
End Date
November 12 2025
Last Update
November 28 2025
Active Locations (1)
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1
Shanghai East Hospital,Affiliated to Tongji University
Shanghai, Shanghai Municipality, China, 200120