The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
214
Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Time frame: within 24 hours after administration of research drug
Percentage of time maintaining target sedation in the entire drug administering time.
Time frame: within 24 hours after administration of research drug
Percentage of subjects receiving rescue sedation
Time frame: within 24 hours after administration of research drug
The number of additional doses of the research drug
Time frame: within 24 hours after administration of research drug]
The total dosage of Fentanyl
Time frame: within 24 hours after administration of research drug
Wake-up time.
Time frame: within 6 hours after stopping the research drug
Stopping the research drug to extubation time.
Time frame: within 6 hours after stopping the research drug
Nursing scale score
Time frame: follow-up period (approx. 5-10 minutes)
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