Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP
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).
Timeline
- Start
- 2025-10-02
- Primary completion
- 2025-11-10
- Completion
- 2025-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intranasal |
| Subject | Dexmedetomidine | Other / unclassified | 50 ug | Intranasal |
| Subject | Dexmedetomidine | Other / unclassified | 100 ug | Intranasal |
| Subject | Propofol | Small molecule | 4 mg/kg | — |
| Subject | Propofol | Small molecule | 12 mg/kg | — |
| Background | Sufentanil | Other / unclassified | 0.1 ug/kg | Intravenous |
Indications
No indication recorded.