Validation of a Nociception Monitor in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.
研究概览
简要总结
Anesthesiology daily practice consists in management of sedation, immobility and analgesia. The monitoring of this last component remains largely based on indirect signs with poor sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an increased demand for more accurate analgesia monitors. Several parameters have been studied in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic tones, and is therefore influenced by pain and analgesia.
MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index, the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number indicating less parasympathetic tone. It has been shown in previous studies under general anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and to increase with opioids administration.
The purpose of this study is to show a correlation between the variation of the ANI with pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of increasing intensity. The investigators hypothesize that an increasing pain score will correlate with decreasing ANI values.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers aged 18-80 years old
排除标准
- •Heart disease
- •Neurological disease
- •Allergy to cutaneous electrodes
- •Chronic pain and/or chronic analgesics consumption
- •Medication affecting the autonomic nervous system
- •Inability to understand a numeric rating scale (NRS)
结局指标
主要结局
ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.
时间窗: Assessed during the entire cycle of stimulation (approx. 30 min)
The ANI is an index that can vary from 0 (maximum pain) to 100 (no pain) in humans. The primary objective of this study will be to record the ANI values all along the time period of the clinical evaluation, while the subjects are submitted to standardized electrical stimulation going from 0 mA (no stimulation) to a maximum of 25 mA (or less according to the subject tolerance). Each stimulation lasts for 3 minutes. During these 3 minutes the ANI is electronically recorded automatically but the Physiodoloris device. The quantitavive value of the index is then analyzed during each stimulation and for all the stimulations. This will allow to evaluate whether it exists any correlation between the ANI values and the intensity of the electrical stimulation.
次要结局
- Blood pressure correlation with ANI(Assessed during the entire cycle of stimulation (approx. 30 min))
- ANI correlation with Numerical Rating Scale (NRS) of pain(Assessed during the entire cycle of stimulation (approx. 30 min))
- Heart rate correlation with ANI(Assessed during the entire cycle of stimulation (approx. 30 min))
研究者
Philippe Richebé
M.D.
Maisonneuve-Rosemont Hospital