A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

December 9, 2019

Primary Completion Date

May 23, 2020

Study Completion Date

June 22, 2020

Conditions
Induction and Maintenance of General Anesthesia
Interventions
DRUG

HSK3486

The induction dose is 0.4mg/mg. The initial maintenance dose of the first 6 subjects is 1 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 6 subjects, so as to explore the optimal initial maintenance dose. The range of the initial maintenance dose is 1 (± 0.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 0.5 mg/kg/h, and the maximum should not be more than 1.5 mg/kg/h.

DRUG

Propofol

The induction dose is 2.0mg/mg. The initial maintenance dose of the first 2 subject is 5 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 2 subjects, so as to explore the optimal initial maintenance dose. The adjustment range of the initial maintenance dose is 5 (± 2.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 2.5 mg/kg/h, and the maximum should not be more than 7.5 mg/kg/h.

DRUG

Propofol HSK3486

The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.

Trial Locations (1)

Unknown

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

NCT04048811 - A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients | Biotech Hunter | Biotech Hunter