HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK3486, propofol.
- Who it may be relevant to
- Registry conditions: General Anesthetic. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3b Clinical Study to Evaluate the Efficacy and Safety of HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
Overview
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
- Drug HSK3486
HSK3486 for induction of general anesthesia. - Drug propofol
Propofol for induction of general anesthesia
Primary outcome measures
- Success rate of GA induction [Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]
Secondary outcome measures (2)
- 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. [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. [Time frame: Up to 8 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07510945 · HSK3486-401