Exploration of Autonomic Nervous System by Photoplethysmography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis)
研究概览
简要总结
The autonomic nervous system state (ANSS) and the autonomic nervous system state index (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been recently advocated as a measure of sympathetic activity in the anesthetized patients, but their validity has not been yet demonstrated. We will conduct a study aiming to assess if ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in healthy humans under general anaesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 50 years
- •American Society of Anaesthesiologists status I and II
排除标准
- •hypertension requiring pharmacological treatment or chronic cardiovascular disease
- •arrhythmic cardiac disease (atrial fibrillation, atrial flutter, ectopic beats >5% of normal sinus beats)
- •history of alcohol or drug abuse
- •obesity (BMI>30)
- •diabetes or other endocrine pathology (thyroidal or adrenal)
- •peripheral neuropathy or any kind of chronic neurological disease
结局指标
主要结局
autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis)
时间窗: 120 min
assessment of autonomic nervous system activity measured by pulse-photoplethysmography and heart rate variability analysis
次要结局
- agreement of photoplethysmography and heart rate variability(120 min)
研究者
Riccardo Colombo
autonomic nervous system analysis during laparoscopy
ASST Fatebenefratelli Sacco