Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml)
研究概览
简要总结
Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate, stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.
详细描述
Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves, during a slow, steady-sate, stepped target controlled infusion of Propofol using Schnider's pharmacologic model. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •american society of anesthesiologists status I or II age >18 years fasted at least 8 hours BMI<30
排除标准
- •any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)
研究组 & 干预措施
propofol slow infusion
(healthy volunteers, non invasive monitoring and O2 supply via nasal cannula) Target controlled infusion of propofol using Schnider´s pharmacokinetic parameters in a slow, stepped fashion. beginning at Cp 0.5 mcg/ml and increasing in 0.5 mcg/ml every 7 minutes until LOC occurred, then a prolonged step of 14 minutes (2 samples), increase 2 steps further and then decrease in 0.5 mcg/ml steps until ROC and a 7 minute registry after ROC.
Blood sampling for propofol plasma level every 7 minutes (at the end of each step, allowing for pseudo-equilibrium condition.
32 channel-EEg and BIS continuous monitoring
干预措施: propofol targel controlled infusion (Drug)
结局指标
主要结局
plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml)
时间窗: 2 hours (during slow steady-state concentration propofol infusion)
determination of plasma concentration of PROPOFOL at the time of Loss of Consciousness and the time of recovery of consciousness during the 7-minute step infusion. Provided it is a slow increasing infusion we assume a pseudo-equilibrium state between plasma and effect site. the existence of a difference between these two values will support the hypothesis of neuronal inertia
次要结局
- Bispectral Index (BIS) al LOC and ROC(2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL)
- Pharmacodynamic curve for propofol.(2 hours)
- PROPOFOL effect site concentration during infusion(2 hours)
研究者
Pablo Sepulveda
Médico Cirujano
Universidad del Desarrollo