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临床试验/NCT01083797
NCT01083797已完成3 期

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
electroencephalogram pattern

研究概览

简要总结

This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. The hypothesis is that this drugs provides similar changes in EEG pattern.

详细描述

Patients with chronic neurological disorders such as cerebral palsy or autism need to be sedated during electroencephalography (EEG). However, various sedatives and hypnotics affect the outcome of the review and is not shown. Chloral hydrate (CH) is widely used in children, but in this patients it is less effective.Recently, dexmedetomidine (DEX) has been tested because preliminary data suggests that this drug does not affect the EEG. The aim of the present work was to compare the electroencephalogram (EEG) pattern during CH or DEX sedation, to test the hypothesis that both drugs exert similar effects in EEG.Seventeen patients were evaluated during sedation with DEX or CH on separate occasions.The EEG was subjected to qualitative and quantitative analysis. Clinical variables were also compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
12 Years 至 38 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • neurological disorder
  • behavior disorder

排除标准

  • cardiac disease
  • respiratory disease

研究组 & 干预措施

dexmedetomidine, chloral hydrate

Other

sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

干预措施: Dexmedetomidine (Drug)

dexmedetomidine, chloral hydrate

Other

sedation with dexmedetomidine or chloral hydrate on separate occasions in the same patients

干预措施: Chloral Hydrate (Drug)

结局指标

主要结局

electroencephalogram pattern

时间窗: twenty minutes

Qualitative analysis: identification of the deepest phase of sleep achieved during the examination, evaluation of background activity (normal, fast activity increased or slow activity increased). Quantitative analysis: density, duration, and amplitude of sleep spindles, spectral power and dominant frequence.

次要结局

  • Effective sedative(twenty minutes)
  • Adverse effects(Two hours)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renato Santiago Gomez

Magda Lourenço Fernandes

Federal University of Minas Gerais

研究点 (1)

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