Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Spectral analysis of heart rate variability with a bispectral index of 25
研究概览
简要总结
Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA risk classification 1 or 2,
- •scheduled for middle ear surgery, or cardiovascular ANS activity.
排除标准
- •preoperative medications that interfere with the autonomic nervous system
- •preoperative medications that interfere with the central nervous system
研究组 & 干预措施
Sevoflurane
General anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.
干预措施: Sevoflurane (Drug)
Sevoflurane
General anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.
干预措施: Remifentanil (Drug)
Propofol
General anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.
干预措施: Propofol (Drug)
Propofol
General anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Spectral analysis of heart rate variability with a bispectral index of 25
时间窗: During surgical procedure
Fast Fourier Transform applied to heart rate signal recording
Spectral analysis of heart rate variability with a bispectral index of 55
时间窗: During surgical procedure
Fast Fourier Transform applied to heart rate signal recording
次要结局
未报告次要终点
研究者
Pr Isabelle CONSTANT
Professor
Hôpital Armand Trousseau