The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily 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
60
Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h
Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection
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 and the average dosage of rescue sedation
Time frame: within 24 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.
Time frame: within 24 hours after administration of research drug
The number of times to change the infusion rate
Time frame: within 24 hours after administration of research drug
Wake-up time.
Time frame: within 8 hours after stopping the research drug
Evaluation of nursing difficulty.
Time frame: follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.
Time frame: at the time of extubation
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