The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Ramsey Sedation Scale
研究概览
简要总结
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.
详细描述
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 18-65 years old,
- •ASA Ⅰ-Ⅲ level;
- •Sign an informed consent form.
排除标准
- •1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.
研究组 & 干预措施
normal group
BMI: ≥18.5 and <24
干预措施: Remimazolam (Drug)
overweight group
BMI: ≥24 and <30
干预措施: Remimazolam (Drug)
obese group
BMI: ≥30
干预措施: Remimazolam (Drug)
结局指标
主要结局
Ramsey Sedation Scale
时间窗: 1 day
Using the Ramsey Sedation Scale scoring table ranging from 1-6 to evaluate if the sedation is successful 1point: Patients are anxious, restless or irritable; 2point: Patients cooperative, well-oriented and quiet; 3point: Patients fall asleep and respond only to commands; 4point: Patients fall asleep and respond quickly to eyebrow taps or loud auditory stimuli; 5point: Patients fall asleep and are blunt to respond to eyebrow taps or loud auditory stimuli; 6point: Patients fall asleep and do not respond to the above stimuli.
次要结局
- Time records(1 day)
- Use of drugs(1 day)
- Incidence of PACU Adverse Reactions(1 day)
- Incidence of Treatment-Emergent Adverse Events(2 days)
- Respiratory suppression incidence(1 day)