NCT06391931已完成3 期
A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2024年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Success rate of anesthesia
研究概览
简要总结
A multicenter, open, controlled, Phase III clinical study to evaluate the efficacy and safety of Cipepofol injection for general anesthesia in pediatric patients 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
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥2 years old and < 18 years old, gender is not limited;
- •Selective surgery requiring tracheal intubation, mechanical ventilation and general anesthesia, with an estimated anesthetic time of 30 to 120 minutes;
- •Intravenous anesthesia is suitable for both induction and maintenance of general anesthesia;
- •ASA grade I-II;
- •Before any activities related to the trial, the child's guardian or his/her guardian should sign the informed consent.
排除标准
- •The type of operation is emergency rescue operation or emergency rescue is required during the operation or blood transfusion may be required according to the researchers;
- •Patients with contraindications to general anesthesia or who have a history of anesthesia accidents;
- •Known or suspected allergy to excipients in propofol injection, Cipepofol injection excipients (soybean oil, glycerol, triglyceride, yolk lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, atropine, etc., and their active ingredients; Contraindications of propofol injection;
- •Prior to screening/baseline, the following medical history or evidence of increased risk of sedation/anesthesia was collected and was determined by the investigator to be inappropriate: Cardiovascular system diseases: severe congenital heart disease (such as tetralogy of Fallot, etc.), severe arrhythmias (such as tachycardia/bradycardia requiring medical treatment, degree III atrioventricular block), severe heart failure, etc.; Respiratory diseases: respiratory insufficiency, history of bronchospasm/asthma requiring treatment within 1 month prior to screening, acute upper respiratory infection with obvious fever, wheezing, or phlegm-producing cough within 1 week prior to baseline; Craniocerebral diseases: history of craniocerebral injury, convulsion, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; Or a known history of mental disorders, such as seizures, schizophrenia, mania, long-term use of psychiatric drugs, cognitive dysfunction; Gastrointestinal diseases: gastrointestinal retention, active bleeding, may lead to reflux aspiration and other conditions; a history of uncontrolled, clinically significant disease of the liver, kidney, hematological, nervous, or metabolic system; Patients with severe infection, trauma or major surgical operation within 4 weeks prior to screening; A history or family history of malignant hyperthermia.
- •There are any of the following respiratory management risks within 1 week before screening: Asthma attacks, wheezing; Patients with failed tracheal intubation experience; The investigators assessed the risk of difficulty with mask ventilation or intubation.
- •Participants who have participated in any drug clinical trial within 1 month before screening;
- •Laboratory examination indicators in the screening period/baseline period meet the following standards and are confirmed by review: alanine aminotransferase and/or ASpartate aminotransferase ≥ 5.0× Upper limit of normal (ULN); Total bilirubin ≥3.0×ULN; serum creatinine ≥2.5×ULN.
- •Women who are fertile (i.e. post-menarche) and do not wish to use contraception throughout the trial period;
- •Paediatric population requiring special care or supervision by courts/social welfare institutions;
- •Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.
研究组 & 干预措施
Cipepofol group
Experimental
干预措施: Cipepofol (Drug)
Propofol group
Active Comparator
干预措施: Propofol (Drug)
结局指标
主要结局
Success rate of anesthesia
时间窗: 24 hours after the end of surgery
Success rate of anesthesia induction and anesthesia maintenance
次要结局
未报告次要终点
研究者
研究点 (1)
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