HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Препарат HSK3486
  HSK3486 for induction of general anesthesia.
• Препарат propofol
  Propofol for induction of general anesthesia

Первичные конечные точки

• Success rate of GA induction [Срок оценки: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: Up to 8 hours]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07510945 · HSK3486-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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