Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from baseline in HRV measurements during noxious stimulation
研究概览
简要总结
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.
The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.
The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients under 55 years-old
- •ASA status 1 or 2
- •scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery)
排除标准
- •history of cardiac or autonomic disease
- •obesity (BMI>30 kg/m2)
- •medication altering autonomic nervous system tone
- •history of eyes surgery
研究组 & 干预措施
opioïd
Different levels of remifentanyl of each group during nociceptive stimulation
干预措施: opioid (remifentanyl) (Drug)
结局指标
主要结局
Change from baseline in HRV measurements during noxious stimulation
时间窗: baseline and 5 minutes
Analyse of HRV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of HRV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the respiratory frequency, which is associated with parasympathetic activity.
change from baseline in APV measurements during noxious stimulation
时间窗: baseline and 5 minutes
Analyse of APV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of APV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the arterial pressure, which is associated with parasympathetic activity.
次要结局
- Change from baseline in pupil change during noxious stimulation(baseline and 5 minutes)
- change from baseline in heart rate during noxious stimulation(baseline and 5 minutes)
- Change from baseline in BIS (Bispectral Index) during noxious stimulation(baseline and 5 minutes)
- change from baseline in systolic blood pressure during noxious baseline(baseline and 5 minutes)
- Change from baseline in diastolic blood pressure during noxious stimulation(basline and 5 minutes)