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临床试验/NCT06061159
NCT06061159已完成4 期

The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction:a Randomised,Double-blind Clinical Trial

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
the time of the loss of consciousness(LOC)

研究概览

简要总结

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.

详细描述

This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different 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
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • with American Society of Anesthesiologists (ASA) physical status I or II;
  • aged 1-12 years;
  • children with weight for age within the normal range;
  • were scheduled general anesthesia surgery

排除标准

  • Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
  • contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
  • recently respiratory infection, mental disorder;
  • other reasons that researchers hold it is not appropriate to participate in this trial.

研究组 & 干预措施

1-3years old

Experimental

single intravenous bolus remimazolam about 5min before general anesthesia induction

干预措施: Remimazolam besylate (Drug)

3-6years old

Experimental

single intravenous bolus remimazolam about 5min before general anesthesia induction

干预措施: Remimazolam besylate (Drug)

6-12years old

Experimental

single intravenous bolus remimazolam about 5min before general anesthesia induction

干预措施: Remimazolam besylate (Drug)

结局指标

主要结局

the time of the loss of consciousness(LOC)

时间窗: during anaesthetic induction

Modified Observers Assessment of Alertness/Sedation (MOAA/S) score of 1 or deeper within 1 minute, and maintained until the end of the 5-minute observation period.

次要结局

  • Modified observer's assessment of alertness/sedation(MOAA/S)scale(Every 1 minutes after single intravenous bolus remimazolam)
  • BIS(Every 1 minutes after single intravenous bolus remimazolam)
  • Recovery time(Within up to 30 minutes after child's first eye opening in the postoperative period)
  • Number of children with adverse effects(Up to 24 hours including preoperative, intraoperative, and postoperative periods)
  • Rate of Pediatric anesthesia emergence delirium(Within up to 15-30 minutes after child's first eye opening in the postoperative period)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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