NCT03753217已完成不适用
Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- qCON monitoring during maintenance of anesthesia
研究概览
简要总结
Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 above 18 years,
- •Patients affiliated to a national insurance scheme or benefiting from such a program,
- •Patients having given their written consent,
- •Patients that must benefit from a general anesthesia by intravenous drugs (propofol and remifentanil),
- •For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number.
排除标准
- •Pregnant or breast-feeding Women,
- •Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,
- •Patients having a contraindication to Propofol and/or to Remifentanil.
研究组 & 干预措施
qCON Monitor
Experimental
Simultaneous measurement of BIS and qCON
干预措施: qCON Monitor (Device)
结局指标
主要结局
qCON monitoring during maintenance of anesthesia
时间窗: Up to 10 hours
Measurement of qCON values during maintenance of anesthesia
BIS monitoring during maintenance of anesthesia
时间窗: Up to 10 hours
Measurement of BIS values during maintenance of anesthesia
次要结局
- Burst Suppression ratio retrieved by BIS monitoring(One day)
- qCON monitoring during induction of anesthesia(One day)
- BIS monitoring during recovery of anesthesia(One day)
- Burst Suppression ratio retrieved by qCON monitoring(One day)
- Periods of loss of signal of qCON(One day)
- Periods of loss of signal of BIS(One day)
- BIS monitoring during induction of anesthesia(One day)
- qCON monitoring during recovery of anesthesia(One day)
- qNOX monitoring during anesthesia(One day)
- Intraoperative memorising(One day)
研究者
研究点 (2)
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