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临床试验/NCT00379886
NCT00379886Unknown不适用

Comparison of Thiopental and Propofol as Anaesteticum During ECT

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Duration of seizures

研究概览

简要总结

Electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. General anesthesia is used during the treatment. Since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used.

Methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric departments.

Several studies have shown that Propofol reduce seizure duration in comparison with barbiturates. So far, no studies have demonstrated any clinical implications of the reduced seiziure duration. However, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ECT was used.

The aim of this study is to compare the clinical effect of ECT in patients anesthesized with either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found with Propofol as anestheticum will increase the number of treatments needed to clinial respons. Furthermore we want to study differences in EEG-relate parameters previously shown to have prognostic value. Hospitalized patients with major depression, who is to be treated with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated with Hamilton depression scale and BDI before treatment, after six treatments and when treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE to evaluate their degree of cognitive impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

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

  • Major depression, hospitalized

排除标准

  • age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases

结局指标

主要结局

Duration of seizures

Number of ECT-treatments required to treat depression

Amount of energy required to initiate seizure

次要结局

  • EEG-related parameters
  • Changes in seizure-threshold
  • Cognitive impairment
  • Haemodynamic parameters

研究者

申办方类型
Other

研究点 (2)

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