Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sedation induction time
研究概览
简要总结
As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.
详细描述
Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with American Society of Anesthesiologists (ASA) physical status I or II#;
- •aged 3#12 years#;
- •children with weight for age within the normal range#;
- •were scheduled to have a gastroscopy;
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 and esketamine;
- •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
Group L
Low-dose esketamine
干预措施: Remimazolam besylate and low-dose Esketamine (Drug)
Group M
Medium dose esketamine
干预措施: Remimazolam besylate and Medium dose Esketamine (Drug)
结局指标
主要结局
Sedation induction time
时间窗: during anaesthetic induction
the patients' unresponsiveness to the mild shaking of their shoulder
次要结局
- Modified observer's assessment of alertness#sedation#MOAA/S#scale(1 minutes after single intravenous bolus remimazolam)
- Recovery times(Within up to 30 minutes after operation)
- VAS(The difficulty of gastroscope insertion)(Moment of endoscopic insertion)
- Number of children with adverse effects(Within 24 hours after completion of gastroscopy.)