Study of Cortical Cerebral Response and Neurovegetative Response to a Nociceptive Stimulus Among Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli
研究概览
简要总结
Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.
However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.
The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.
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
- •Healthy volunteer over 18 years old
- •signed informed consent
- •affiliated to a social security
排除标准
- •Chronic pathology requiring chronic treatment
- •Cardiac rhythm disorders, pacemaker, cardiotropic treatment
- •Taking opioid analgesics during the previous week
- •Painful chronic, or migraine
- •Pathology of the hand, acrosyndrome, carpal tunnel syndrome
- •Pregnancy
- •People placed under protection of justice
结局指标
主要结局
Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli
时间窗: Day 1
Simultaneous scheme of cortical activation and neuro-vegetative responses secondary to controlled nociceptive stimuli will be defined as the occurrence of at least one among the following: * Changes of time-frequency distribution of the electroencephalographic activity during phasic or tonic pain stimulation, compared to a prior baseline period. * Recording of cortical evoked responses during phasic pain stimulation in a time latency range between 100-500 msec. * Changes in parasympathetic tone measured by Analgesia/Nociception Index (ANI) method (threshold of 50/100) during phasic or tonic stimulation * Recording of the skin conductance reflex (skin sympathetic response) during phasic or tonic stimulations
次要结局
- Qualitative Change of ANI Value during phasic stimulation(Day 1)
- EEG time-frequency analysis during tonic pain stimulation(Day 1)
- EEG time-frequency analysis during phasic pain stimulation(Day 1)
- Pick-to-pick amplitude of evoked responses to phasic stimulation(Day 1)
- Latency of evoked responses to phasic stimulation(Day 1)
- Quantification of skin sympathetic response during tonic stimulation(Day 1)
- Qualitative Change of ANI Value during tonic stimulation(Day 1)
- Quantification of skin sympathetic response during phasic stimulation(Day 1)
- Selection of dominant configuration of pattern in terms of sensitivity / specificity of the response to different types of nociceptive stimulation(Day 1)