ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Loss of consciousness within 5 minutes
研究概览
简要总结
It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia
排除标准
- •Patients scheduled for liver surgery
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus
- •Liver disease
- •Kidney disease
- •Intolerance or hypersensitivity to benzodiazepine
- •Heart failure
- •Peripheral vascular disease
- •Obstuctive lung disease
- •Patients scheduled for regional anesthesia before general anesthesia
研究组 & 干预措施
1 (0.02 mg/kg, age<65)
Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
干预措施: 0.02 mg/kg, age<65 (Drug)
2 (0.07 mg/kg, age<65)
Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
干预措施: 0.07 mg/kg, age<65 (Drug)
3 (0.12 mg/kg, age<65)
Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
干预措施: 0.12 mg/kg, age<65 (Drug)
4 (0.17 mg/kg, age<65)
Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
干预措施: 0.17 mg/kg, age<65 (Drug)
5(0.22 mg/kg, age<65)
Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
干预措施: 0.22 mg/kg, age<65 (Drug)
6(0.27 mg/kg, age<65)
Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
干预措施: 0.27 mg/kg, age<65 (Drug)
7 (0.02 mg/kg, age≥65)
Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
干预措施: 0.02 mg/kg, age≥65 (Drug)
8 (0.07 mg/kg, age≥65)
Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
干预措施: 0.07 mg/kg, age≥65 (Drug)
9 (0.12 mg/kg, age≥65)
Remimazolam of 0.12 mg/kg will be infused in patients aged≥65.
干预措施: 0.12 mg/kg, age≥65 (Drug)
10 (0.17 mg/kg, age≥65)
Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
干预措施: 0.17 mg/kg, age≥65 (Drug)
11 (0.22 mg/kg, age≥65)
Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
干预措施: 0.22 mg/kg, age≥65 (Drug)
12 (0.27 mg/kg, age≥65)
Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
干预措施: 0.27 mg/kg, age≥65 (Drug)
结局指标
主要结局
Loss of consciousness within 5 minutes
时间窗: At 5 minutes after infusion
Loss of consciousness will be evaluated at 5 minutes after infusion.
次要结局
- blood pressure(At 5 minutes after infusion)
- Time to loss of consciousness(At 5 minutes after infusion (time to loss of consciousness))
- sedline(At 5 minutes after infusion)
- heart rate(At 5 minutes after infusion)
研究者
Dong Woo Han
Associate professor
Gangnam Severance Hospital