This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Loading Dose:0.1 mg/kg,Maintenance Dose:Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.
Loading Dose:0.5 mg/kg,Maintenance Dose:Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Mean duration of qualified sedation
the mean duration of RASS being in the range of -1 to -2 per hour during the study medication provided that no remedial medication is used
Time frame: Within 96hours of administration
Time to recovery
the time for the subject to recover from sedation to full recovery of consciousness (RASS ≥ 0) after discontinuation of drug administration.
Time frame: Within 24 hours after administration
Time to extubation
the time from intubation (applicable to patients who undergoes intubation after entering the ICU)/ICU admission (applicable to patients with intubation before entering the ICU) to extubation or the time from drug discontinuation to extubation
Time frame: Within 24 hours after administration
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