Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hypotension incidence related to sevoflurane
研究概览
简要总结
Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.
详细描述
This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participant will not know allocation (sevoflurane concentration) and will be under general anesthesia
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands experiment, is voluntary, signs informed consent;
- •Does not take medication that influences arterial pressure;
- •Normotensive.
排除标准
- •Received any medication that influences arterial pressure before experiment;
研究组 & 干预措施
Young patients
Patients between 19 and 40 years-old
干预措施: Sevoflurane (Drug)
Elder patients
Older than 65
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Hypotension incidence related to sevoflurane
时间窗: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Any mean arterial pressure drop \> 10% compared to baseline
次要结局
- Systolic hypotension(During the first 10 minutes after end tidal sevoflurane concentration stabilizes)
- Diastolic hypotension(During the first 10 minutes after end tidal sevoflurane concentration stabilizes)
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of Anesthesiology
Brasilia University Hospital