This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
135
Loading Dose:0.1 mg/kg, infused with 4 min ± 30 s; 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. Range of maintenance dose: 0.06-0.8 mg/kg/h
Loading Dose:0.5 mg/kg, infused with 4 min ± 30 s Maintenance Dose:Maintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose: 0.3-4 mg/kg/h
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Success rate of sedation
1\) The time period during which the RASS is in the range of +1 to -2 accounts for ≥ 70% of the total duration of study administration and 2) Remedial treatment is not used.
Time frame: Within 24 hours of administration
Mean qualified rate of sedation
Defined as the percentage of time period during which the RASS is in the range of +1 to -2 relative to the total duration of study administration
Time frame: Within 24 hours of administration
Use of study drug
the loading doses of HSK3486 and propofol, mean maintenance dose and total dose per unit weight per hour of HSK3486 or propofol, and the number of dose modifications and the number of top up doses during the maintenance period
Time frame: Within 24 hours of administration
Dose of remedial drugs per unit weight
the mean dose per unit weight per hour of other sedatives used to maintain the target sedation (RASS within +1 to -2 points)
Time frame: Within 24 hours of 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
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
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Incidence of adverse events
safety endpoits
Time frame: From day -1 to 24 hours after administration