Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hemodynamic changes
研究概览
简要总结
Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes.
Changes from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position.
The aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position.
The secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.
详细描述
A total of 20 patients scheduled for elective lumbar spinal surgery in the knee-chest position were included. In addition to standard anesthesia monitoring, bispectral index and noninvasive cardiac output monitoring were undertaken. The study was carried out in 2 parts. In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness: reduction calculated using a predefined formula, and (2) before positioning: reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Lumbar spinal condition for surgical treatment in knee-chest position
排除标准
- •Severe ischemic heart disease
- •Congestive heart failure
- •Atrial fibrillation or flutter
- •Body mass index > 35 kg/m2
- •Glasgow Coma Scale < 15
- •Dementia disease
- •History of drug abuse or addiction
- •Consumption of opioid medication
- •Pre-operative administration of midazolam
研究组 & 干预措施
Two protocolled propofol reductions
In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness-reduction calculated using a predefined formula, and (2) before positioning-reduction equal to the average percentage decrease in CO after knee-chest position in phase
干预措施: Propofol reduction (Drug)
结局指标
主要结局
Hemodynamic changes
时间窗: Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)
Changes from baseline in cardiac output and comparison of the changes between both groups.
次要结局
- Pharmacokinetic changes(Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2))
研究者
Daniela Chalo
Principal Investigator
University of Salamanca