The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
研究概览
简要总结
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)
排除标准
- •Pregnant women,
- •Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
- •Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- •History of neurological disorder or central brain lesion, of muscle disease,
- •Patient carrying a pacemaker,
- •Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
- •Alcoholic patients and patients taking opiates,
- •Surgery with extracorporeal circulation,
- •Surgical position incompatible with an adequate positioning of the probe.
研究组 & 干预措施
patients receiving balanced anesthesia
干预措施: propofol, remifentanil, atracurium, sevoflurane (Drug)
patients receiving balanced anesthesia
干预措施: EEG monitoring (Device)
patients receiving iv anesthesia
干预措施: propofol, remifentanil, atracurium (Drug)
patients receiving iv anesthesia
干预措施: EEG monitoring (Device)
结局指标
主要结局
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
时间窗: at the end of each case
Statistical analysis of concordance
次要结局
- Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence(at the end of each case)