This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administered with HSK3486 at a loading dose of 0.1-0.2 mg/kg via intravenous pump. Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.
Administered with Propofol at a loading dose of 0.5-1.0mg/kg via intravenous pump. Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
Mean time to sedation
Defined as the mean time during which the hourly RASS is in the range of +1- -2 during the study treatment
Time frame: at day 1
Study drug use
Including the loading dose, maintenance dose, additional dose of HSK3486 and propofol, average unit weight dose per hour of HSK3486 or propofol, total and hourly average numbers of dose adjustments
Time frame: at day 1
Minimum maintenance dose
Defined as the minimum dose to maintain the target sedation level (RASS between +1 and -2) of the subject for ≥ 2 h and ≥ 4 h during the administration period
Time frame: at day 1
Unit weight dose of remedial drug
Defined as the average hourly unit weight dose of sedatives other than propofol administered for maintaining a target sedation level (RASS between +1 and -2) during the administration period
Time frame: at day 1
Unit weight dose of remifentanil
Defined as the average hourly unit weight dose of remifentanil for analgesia during the administration period
Time frame: at day 1
Extubation time
Defined as the time from ICU admission to extubation (applicable for subjects who have been intubated before admitted to ICU) or the time from intubation to extubation (applicable for subjects who are intubated after admitted to ICU); for withdrawals, the time of extubation is calculated according to the time of discontinuation; if the extubation does not occur within 24 h of administration, the time of extubation is recorded as 24 h
Time frame: at day 1
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Recovery time
Defined as the time to recover from sedation status to awaken status (RASS ≥ 0) after drug discontinuation, accurate to the minute; if RASS is ≥ 0 at discontinuation, the recovery time is recorded as 0
Time frame: at day 1