Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index
研究概览
简要总结
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
详细描述
Introduction:
There is a large intra-and interindividual variability in the effect of propofol. To deal with this problem, a real-time monitoring and therefore a more accurate titration of anesthetic agents is proposed. Brain function monitors based on a processed analysis of EEG (Electroencephalogram) can help to control pharmacodynamic effects of hypnotic agents. PSI values provide a measurement of the hypnotic effect of propofol. It will be observed an inverse correlation between the propofol infusion rate and the PSI value.
Objectives:
To design a computer program to record simultaneously the propofol infusion rate, PSI and Electromyogram (EMG).
To study the correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classification of I, II, or III
- •Patient signed an informed consent
排除标准
- •Patients with prior neurological disease, epilepsy or stroke.
- •Patients who are receiving drug therapy that may alter processed EEG monitoring and decrease the PSI accuracy.
- •American Society of Anesthesiologists classification IV or higher
结局指标
主要结局
EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index
时间窗: During general anaesthesia in the operating room for a scheduled surgery.
The values from the SEDLine ® monitor inversely correlate with the rate of infusion of propofol. Changes in that velocity correspond to changes in the effect site (CNS) and are related to the PSI values displayed in the monitor.
次要结局
- Time from discontinuation of intravenous agents to open eyes to order(In the operation room at the end of surgery)