This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40 subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly enter into propofol induction + HSK3486 maintenance group for study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
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.
The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.
Peking University First Hospital
Beijing, China
Success rate of anesthesia maintenance
During the maintenance of anesthesia, the subject is not recovered and no remedial anesthetic is used
Time frame: During maintenance of general anesthesia on day 1
Number of patients with adverse events
Safety endpoints
Time frame: Pre-dose to 48 hours post-dose
Success rate of anesthesia induction
During the induction of anesthesia, the subject achieves successful induction (i.e., MOAA/S ≤ 1) after administration of the study drug (up to 2 additional doses), and no remedial anesthetic is used.
Time frame: During induction of general anesthesia on day 1
Success rate of anesthesia
The proportion of subjects who are successfully induced and successfully maintain anesthesia in all subjects.
Time frame: During induction and maintenance of general anesthesia on day 1
Changes in Bispectral index
Bispectral index (BIS) is used to adjust the administration dose during anesthesia maintenance to maintain BIS at 40-60
Time frame: During maintenance of general anesthesia on day 1
Time to successful induction of anesthesia
A period of time from the start of the first administration of the study drug to the first time when MOAA/S is ≤ 1.
Time frame: Time to successful induction of anesthesia on day 1
Time to recovery from anesthesia
6.Record the time when MOAA/S = 5 is reached for the first time.
Time frame: A period of time from discontinuation of the study drug to recovery after the end of surgery on day 1.
Time to respiratory recovery
Respiratory rate ≥ 8 breaths/min and the tidal volume ≥ 5 mL/kg.
Time frame: A period of time from discontinuation of the study drug to respiratory recovery after the end of surgery on day 1.
Time to extubation
Time frame: A period of time from discontinuation of the study drug to extubation after the end of surgery on day 1.
Time to leaving the operating room
Time frame: A period of time from discontinuation of the study drug to leaving the operating room after the end of surgery on day 1.
Time to leaving postanesthesia care unit(PACU)
Time frame: A period of time from discontinuation of the study drug to leaving PACU after the end of surgery on day 1.
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