Monitoring Depth of Anesthesia With the SedLine Facilitates Motor Evoked Potential (MEP) Monitoring During Corrective Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is a composite measure of the motor evoked responses over the duration of the surgical procedure utilizing the "area under the curve" (AUC, volt-seconds) of the response time series
研究概览
简要总结
To determine if using usual clinical practice plus a depth of anesthesia monitor, SedLine, to guide anesthetic administration improves the quality and ease of MEP monitoring in patients undergoing corrective spinal procedures.
详细描述
Motor Evoked Potential (MEP) monitoring during spine surgery is now used routinely. However it is affected by a variety of anesthetics including fluctuating and/or excessively deep or light levels of anesthesia. A common problem is maintaining an overall constancy and adequacy of anesthesia. Individual patients' responses to anesthesia can differ greatly from population means and can complicate the interpretation of MEPs. False alarms can have significant consequences. One strategy to minimize the anesthetic induced variability of MEPs, and thereby improve the monitoring overall, is to keep the patient's anesthetic state (or "depth") in a narrow range during surgery. This study tests whether using a commercially available depth of anesthesia monitor in addition to usual clinical practice improves the quality of MEPs.
The hypothesis of this study is that the SedLine Monitor, which uses an EEG derived assessment of anesthetic depth, may facilitate MEP monitoring if it is kept within a narrow range during spine surgery. Because SedLine recommends maintaining their Index between 30 and 40 during surgical anesthesia, this is the range used in the primary hypothesis.
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 undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
- •18 yrs of age or older
排除标准
- •Minors, prisoners and those unable to consent for themselves.
结局指标
主要结局
The primary outcome of this study is a composite measure of the motor evoked responses over the duration of the surgical procedure utilizing the "area under the curve" (AUC, volt-seconds) of the response time series
时间窗: End of study
次要结局
- Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability.(end of study)
