Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol in Patients Undergoing Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- sedation score
研究概览
简要总结
Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects.
In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have lower extremity surgery under spinal anesthesia and who want to be sedated
排除标准
- •patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,
结局指标
主要结局
sedation score
时间窗: every 5 minutes when the dose is adjusted up to 1 hour
Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. It has 5 scales from 1 to 5 as followed. 1. responds readily to name spoken in normal tone 2. lethargic response to name spoken in normal tone 3. responds only after name is spoken loudly and/or repeatedly 4. responds only after mild prodding or shaking 5. does not respond to mild prodding or shaking After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced.
次要结局
- airway obstruction score(every 5 minutes when the dose is adjusted up to 1 hour)