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临床试验/NCT02386995
NCT02386995已完成不适用

Comparison of Bispectral Index and Entropy Monitoring in Patients Undergoing Internalization of Deep Brain Simulation

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices

研究概览

简要总结

The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological conditions such as Parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.

详细描述

Deep brain simulation (DBS) is an increasingly popular treatment for movement and psychiatric disorders such as Parkinson's disease and dystonia. These patients are quite sensitive to anesthetics and use of depth of anesthesia monitors are often needed to titrate the anesthetics. The calibration of BIS and entropy monitors has been done only on subjects with no neurological diseases. The investigators plan to record BIS and entropy readings during general anesthesia (GA) for the internalization of DBS electrodes. This would be useful as there are very few studies in this subset of patients with regards to DOA monitoring. Ashraf argued that the EEG may be altered under these circumstances and hence produce invalid BIS readings. Pemberton et al. studied patients undergoing tumour surgery using a sleep- awake-sleep anaesthesia technique. They found a poor correlation between BIS values and the observer's assessment of anesthesia level, suggesting that BIS is not a reliable tool for patients with brain abnormalities. The purpose of this study was to investigate whether BIS and entropy are helpful in titrating DOA in patients undergoing neurosurgical procedures or suffering from neurological diseases as they were frequently excluded from validation studies of the BIS monitoring device.

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

入选标准

  • Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.

排除标准

  • lack of informed consent
  • language barrier
  • those that are transferred to an intensive care unit postoperatively.

结局指标

主要结局

Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices

时间窗: One day

The trends of Bispectral (BIS) and Response entropy (RE) at different study time points. Bispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state). Values below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lashmi Venkatraghavan

Dr.

University Health Network, Toronto

研究点 (1)

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