This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
The success rate of induction of general anesthesia
To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement.
Time frame: during induction of general anesthesia on day 1
Time from start of IMP administration to loss of eyelash reflex
Time frame: during induction of general anesthesia on day 1
Time from start of IMP administration to loss of consciousness
Time frame: during induction of general anesthesia on day 1
Time from start of IMP administration to intubation and the intubation reaction
Time frame: during induction of general anesthesia on day 1
Mini-Mental State Examination (MMSE) total scores(0-30) by time point
Change from baseline in Mini-Mental State Examination (MMSE) total score
Time frame: Pre-dose to 48 hours post-dose
change from baseline in blood pressure (systolic, diastolic and mean arterial pressure)
safety endpoits
Time frame: pre-dose to 20 minutes post-dose
change from baseline in heart rate
safety endpoits
Time frame: pre-dose to 20 minutes post-dose
change from baseline in arterial oxygen saturation
safety endpoits
Time frame: pre-dose to 20 minutes post-dose
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Number of patients with adverse events
safety endpoits
Time frame: Pre-dose to 48 hours post-dose