Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The success rate of anesthesia induction
研究概览
简要总结
This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of [2,12] and [12,18）age groups.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 years old ≤age<18 years old, regardless of gender;
- •General anesthesia is planned;
- •ASA score grade I ~ II; 4）Able to sign the informed consent.
排除标准
- •Children with general anesthesia contraindications;
- •With diseases that are not suitable for the study in the scheme;
- •Abnormal liver and kidney function in screening stage;
- •Abnormal coagulation function;
- •Serum electrolyte abnormality;
- •Subjects intolerant or allergic to the study drugs;
- •Recently received other narcotic drugs or other drugs that affect the metabolism of study drugs;
- •The child thought to be unsuitable for the study, as determined by the investigator.
研究组 & 干预措施
HR020602 injection
干预措施: HR020602 injection (Drug)
fentanyl injection + remifentanil injection
干预措施: fentanyl injection ； remifentanil injection (Drug)
结局指标
主要结局
The success rate of anesthesia induction
时间窗: Within 5 minutesafter propofol medium /long chain fat emulsion administration
次要结局
- The success rate of anesthesia maintenance(Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia))
- Anesthesia recovery time(The time from stopping using anesthetic drugs (propofol medium/long-chain fat emulsion) to the time when the subject wakes up (opening eyes as instructed))
- The dosage of opioids during anesthesia maintenance period(Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia))
- The incidence and severity of adverse events during the trial(Through study completion, about 3-10 days))
- The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period(Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia))
- Clearance rate (CL), apparent volume of distribution (V) and inter individual variation (CV%) of parameters(PK blood collection are to be performed at 5 time points during Day 1-Day 2))
- The incidence of adverse reactions of the mental system(Within 1 hour after awakening))
- Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)(Through study completion, about 3-10 days))