Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP

NANot yet recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

December 15, 2025

Study Completion Date

December 20, 2025

Conditions
Dexmedetomidine Induced SedationNasal AdministrationSprays
Interventions
DRUG

Dexmedetomidine Injection (nasal spray) + Propofol Injection + Sufentanil Injection

"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"

DRUG

Normal Saline (nasal spray) + Dexmedetomidine Injection (intravenous) + Propofol Injection + Sufentanil Injection

"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)."

DRUG

Regular sedation protocol

"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)."

Trial Locations (1)

200120

Shanghai East Hospital,Affiliated to Tongji University, Shanghai

All Listed Sponsors
collaborator

Shanghai East Hospital of Tongji University

OTHER

lead

Shiyou Wei

OTHER

NCT07204106 - Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP | Biotech Hunter | Biotech Hunter