NCT07510945尚未招募3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Success rate of GA induction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing elective surgery requiring endotracheal intubation.
- •Males or females, aged ≥3 and <18 years old, with ASA-PS I to IV.
- •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.
排除标准
- •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:
- •Subjects with respiratory tract management risks prior to/at screening.
- •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.
研究组 & 干预措施
Propofol
Active Comparator
Propofol for induction of general anesthesia.
干预措施: propofol (Drug)
HSK3486
Experimental
HSK3486 for induction of general anesthesia.
干预措施: HSK3486 (Drug)
结局指标
主要结局
Success rate of GA induction
时间窗: 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.
次要结局
- 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)
- 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)
研究者
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