The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S
研究概览
简要总结
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.
详细描述
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-12 years old,
- •ASA I-II level;
- •Sign an informed consent form.
排除标准
- •Developmental delay or neurological and psychiatric disorders;
- •Severe malnutrition or severe obesity;
- •High risk of stomach fullness and reflux aspiration;
- •Allergic to benzodiazepines and opioids;
- •Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
- •Severe sleep apnea;
- •Abnormal liver and kidney function;
- •Recently participated in other clinical studies.
研究组 & 干预措施
4-6 years group
Age: ≥48 and <84 months
干预措施: Remimazolam (Drug)
7-12 years group
Age: ≥84and <156 months
干预措施: Remimazolam (Drug)
infant group
Age: <48 months
干预措施: Remimazolam (Drug)
结局指标
主要结局
Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S
时间窗: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.
Using the modified MOAA/S scoring table（ranging from 5-0） to evaluate if the sedation is successful. 5 points：Respond quickly to names spoken in a normal tone 4 points：Showing a drowsy reaction to names spoken in a normal tone 3 points：Only react after loudly and/or repeatedly calling the name 2 points：Response immediately after slight stimulation or shaking 1point：Response only occurs after compression of the trapezius muscle that causes pain 0 point：No response after compression of the trapezius muscle
次要结局
- Respiratory Suppression Incidence(The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From the start of drug administration for induction to 24h after the operation.)
- Time Records(The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.)