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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
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.
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
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).
Time frame: Up to 8 hours
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.
Time frame: Up to 8 hours
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