This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h.
First-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h. Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h.
West China Hospital,Sichuan University
Chengdu, China
blood pressure(systolic, diastolic and mean arterial pressure)
safety endpoits
Time frame: from the screening to 3 days post-dose
heart rate
safety endpoits
Time frame: from the screening to 3 days post-dose
respiratory rate
safety endpoits
Time frame: from the screening to 3 days post-dose
blood oxygen saturation
safety endpoits
Time frame: from the screening to 3 days post-dose
Number of patients with adverse events
safety endpoits
Time frame: from the baseline to 3 days post-dose
Richmond Agitation Sedation Scale( scores:+4~-5)
Change from baseline in Richmond Agitation Sedation Scale(RASS) score
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Bispectral index
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Time frame: -30 minutes before administration until the subject is completely awakened post administration on day 1
Terminal elimination half life
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Time frame: -30 minutes before administration until 24 hours post administration on day 1
Total clearance
Time frame: -30 minutes before administration until 24 hours post administration on day 1
Volume of distribution
Time frame: -30 minutes before administration until 24 hours post administration on day 1
plasma concentration at the end of infusion
Time frame: -30 minutes before administration until 24 hours post administration on day 1