跳至主要内容
临床试验/NCT03319004
NCT03319004Unknown不适用

Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia: Comparative Analysis With Bispectral Index

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
27
试验地点
1
主要终点
phase lag entropy score

研究概览

简要总结

For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who require sedation during the spinal anesthesia

排除标准

  • •dementia, CVA patients, patients have problems with communication

研究组 & 干预措施

Compare bispectral index and phase lag entropy

Experimental

干预措施: apply phase lag entropy sensor (Device)

结局指标

主要结局

phase lag entropy score

时间窗: through study completion, an average of 1 year

phase lag entropy score

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

Dong Woo Han

Principal Investigator

Gangnam Severance Hospital

研究点 (1)

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