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Efficacy of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Prospective Randomized Study
In Brief
A clinical study evaluating Dexmedetomidine Injection (nasal spray) + Propofol Injection + Sufentanil Injection, Normal Saline (nasal spray) + Dexmedetomidine Injection (intravenous) + Propofol Injection + Sufentanil Injection, and 1 other intervention for Dexmedetomidine Induced Sedation and 2 related conditions. Completed, enrolled 180 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
1. Preoperative intervention：30 minutes before entering the operating room, 50-100μg of Dexmedetomidine Injection is administered via nasal spray in the anesthesia preparation room. 2. Induction phase：Intravenous injection of Sufentanil Injection (Yichang Renfu Pharmaceutical Co., Ltd.) at a dose of 0.1μg/kg, and Propofol Injection (Jiabo Pharmaceutical, Guangdong, China) at a dose of 1.5-2.0mg/kg (injection time \>30 seconds). During induction, the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/s) score is evaluated every 30±10 seconds; if MOAA/s \>1 after 2 minutes, an additional sedative dose (1/2 of the initial dose, injection time ≥10 seconds) is supplemented until MOAA/s ≤1. 3. Maintenance phase：Continuous intravenous infusion of Propofol Injection at a rate of 4-12mg/kg/h; the dose is adjusted according to Bispectral Index (BIS) to maintain BIS between 40-60. If the patient shows body movement, eye opening, speech or other signs of insufficient se
1. Preoperative intervention：30 minutes before entering the operating room, normal saline is administered via nasal spray in the anesthesia preparation room; 10 minutes before induction, 0.5μg/kg of Dexmedetomidine Injection is given via intravenous injection. 2. Induction phase：Same as Experimental Group ① (intravenous Sufentanil 0.1μg/kg + Propofol 1.5-2.0mg/kg, with MOAA/s monitoring and supplementary dose rules). 3. Maintenance phase：Same as Experimental Group ① (continuous Propofol infusion at 4-12mg/kg/h, BIS-adjusted dose, and supplementary sedation rules for insufficient sedation).
Preoperative intervention：No dexmedetomidine or normal saline nasal spray; only routine preoperative preparation. Induction phase：Same as Experimental Group ① (intravenous Sufentanil 0.1μg/kg + Propofol 1.5-2.0mg/kg, with MOAA/s monitoring and supplementary dose rules). Maintenance phase：Same as Experimental Group ① (continuous Propofol infusion at 4-12mg/kg/h, BIS-adjusted dose, and supplementary sedation rules for insufficient sedation).