A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 9, 2019

Primary Completion Date

July 2, 2019

Study Completion Date

August 27, 2019

Conditions
AnesthesiaSedation
Interventions
DRUG

HSK3486

"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."

DRUG

Propofol

"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."

Trial Locations (1)

Unknown

West China Hospital,Sichuan University, Chengdu

All Listed Sponsors
lead

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

NCT03745625 - A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 | Biotech Hunter | Biotech Hunter