Comparison of the Nociception Monitoring Devices During Cardiac Surgery.
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
- 2
- 主要终点
- SPI values measured at several timepoints during cardiac surgery
研究概览
简要总结
The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.
详细描述
Participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. Participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. NOL and SPI values will be measured during the cardiac surgery procedure. All patients receive oral premedication and standardized anesthesia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery disease of heart valve disorder qualified for the surgical treatment
- •participant understands the course of the trial and its aim
- •participant has given informed written consent
排除标准
- •participant has not given consent
- •neurological or psychical disorders (psychiatric medication)
- •alcohol or substance abuse
- •central nervous system medication (medication for epilepsy or neuropathic pain)
结局指标
主要结局
SPI values measured at several timepoints during cardiac surgery
时间窗: Values are measured during the course of the cardiac surgery procedure
SPI (Surgical Pleth Index) - index measuring nociceptive response based on pulse and pulse amplitude.
NOL values measured at several timepoints during cardiac surgery
时间窗: Values are measured during the course of the cardiac surgery procedure
NOL (Nociception Level Index) - nociception index based on heart rate and its changes, pulse wave amplitude, skin impedance and its changes, temperature and their variations
次要结局
未报告次要终点