General Anesthetic
Conditions
Brief summary
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.
Interventions
DRUGHSK3486
HSK3486 for induction of general anesthesia.
DRUGpropofol
Propofol for induction of general anesthesia
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
\- 1. Subjects undergoing elective surgery requiring endotracheal intubation. 2. Males or females, aged ≥3 and \<18 years old, with ASA-PS I to IV. 3. For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device \[IUD\], abstinence) from the time of consent until 30 days post study drug administration. 4\. Subjects must be able to adhere to the study visit schedule and complete all study assessments.
Exclusion criteria
* 1\. Subjects whose surgery is emergent, or who need emergency treatment during the surgery, or who need transfusion based on the investigator's judgment. 2\. Contraindications to deep sedation/GA or a history of adverse reaction to sedation/GA. 3\. Subjects known to be allergic to excipients in propofol injection, excipients in cipepofol injectable emulsion (soybean oil, glycerol, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium, atropine, and their active ingredients; and to have contraindications to propofol. 4\. Subjects with history or evidence of any of sever system diseases increasing the risk of sedation/anesthesia prior to screening/baseline and deemed unsuitable for participation by the investigator: 5. Subjects with respiratory tract management risks prior to/at screening. 6. Subjects who have participated in clinical studies of any drug within 1 month prior to screening. 7\. Females of childbearing potential (i.e., post-menarche) who are unwilling to use contraception during the entire study period. 8\. Subjects unsuitable for this study for any reason as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of GA induction | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to 8 hours | 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. | Up to 8 hours | 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. |
Outcome results
None listed