This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation. Its primary purpose is to evaluate whether cipepofol is non-inferior to propofol in success of induction of general anesthesia in pediatrics undergoing elective surgery.
None
1. Subjects whose surgery is emergent, or who need emergency treatment during the surgery, or who need transfusion based on the investigator's judgment.
Parallel
HSK3486
DrugHSK3486 for induction of general anesthesia.
propofol
DrugPropofol for induction of general anesthesia
Success rate of GA induction
A successful GA induction will meet both of the following conditions: 1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.
The proportion of subjects (6-17 years old) with any injection-site pain (mild, moderate, severe) at time of drug administration on the NRS ≥1.
Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain).
The proportion of subjects (3-5 years old) with any injection-site pain (mild, moderate, severe) at time of drug administration on the FPS-R ≥2.
Injection-site pain is evaluated during study drug administration using the Faces Pain Scale-Revised (FPS-R), a scale which uses a series of faces ranging from happy (no pain, 0) t(o sad (worst pain, 10) evaluate pain in subjects 3-5 years old.
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