Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- BIS and CVI.
研究概览
简要总结
The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).
详细描述
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •ASA class I and II patients requiring general anesthesia for elective surgical procedures
排除标准
- •patient refusal
- •weight less than 70% or more than 130% of ideal body weight,
- •neurological disorder
- •recent use of psycho-active medication, including alcohol.
研究组 & 干预措施
Group 1 BIS value 30
干预措施: propofol + remifentanil 0 ng/ml (Drug)
Group 2 BIS value 30
干预措施: propofol + remifentanil 2 ng/ml (Drug)
Group 3 BIS value 30
干预措施: propofol + remifentanil 4 ng/ml (Drug)
Group 4 BIS valaue 30
干预措施: propofol + remifentanil 6 ng/ml (Drug)
Group 1 BIS value 50
干预措施: propofol + remifentanil 0 ng/ml (Drug)
Group 2 BIS value 50
干预措施: propofol + remifentanil 2 ng/ml (Drug)
Group 3 BIS value 50
干预措施: propofol + remifentanil 6 ng/ml (Drug)
Group 4 BIS value 50
干预措施: propofol + remifentanil 6 ng/ml (Drug)
Group 1 BIS value 70
干预措施: propofol + remifentanil 0 ng/ml (Drug)
Group 2 BIS value 70
干预措施: propofol + remifentanil 2 ng/ml (Drug)
Group 3 BIS value 70
干预措施: propofol + remifentanil 4 ng/ml (Drug)
Group 4 BIS value 70
干预措施: propofol + remifentanil 6 ng/ml (Drug)
结局指标
主要结局
BIS and CVI.
时间窗: 2 year
次要结局
未报告次要终点