180
Participants
Start Date
October 15, 2025
Primary Completion Date
December 15, 2025
Study Completion Date
December 20, 2025
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"
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)."
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)."
Shanghai East Hospital,Affiliated to Tongji University, Shanghai
Shanghai East Hospital of Tongji University
OTHER
Shiyou Wei
OTHER