Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Sedation success rate
研究概览
简要总结
To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
详细描述
It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
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, Care Provider, Outcomes Assessor)
盲法说明
Since propofol is white uniform emulsion, and ramazolam is colorless, clear and transparent liquid, anesthesiologists and surgeons may see the color of the study drug during operation, so this study is a single blind clinical study
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-17;
- •ASA Class I-II;
- •Sign the informed consent form.
排除标准
- •Patients with high risk of stomach satiety and reflux aspiration;
- •Patients allergic to the study drug;
- •Obesity or severe malnutrition;
- •Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
- •Hypertension without treatment;
- •Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
- •Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
- •Participate in other clinical studies within 4 weeks.
研究组 & 干预措施
P group
induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: Esketamine (Drug)
P group
induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: Propofol (Drug)
P group
induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: remifentanil (Drug)
R group
induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: Remimazolam (Drug)
R group
induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: Esketamine (Drug)
R group
induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping
干预措施: remifentanil (Drug)
结局指标
主要结局
Sedation success rate
时间窗: Procedure (From the beginning of anesthesia to the end of examination)
Improved observer alertness and sedation score, MOAA/S
次要结局
未报告次要终点