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临床试验/NCT04657575
NCT04657575已完成不适用

Optimisation of Electro-Convusions-Therapie (ECT) Based on ASTI (Anaesthesia to Intervention Time Interval) Versus Narcotrend - a Randomised Prosepctive

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Convulsion Quality

研究概览

简要总结

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression.

  • Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

详细描述

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression.

  • Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 -90 years
  • Signed informed consent
  • Severe depressive disorder

排除标准

  • Age < 18 or > 90
  • denial of the patient
  • Impossibility to fix Narcotrend electrodes
  • Patients unable to consent
  • Pregnancy

结局指标

主要结局

Convulsion Quality

时间窗: One hour

Adequate seizure quality was defined as \> 20 seconds motor response on the right forearm, \>25 seconds EEG seizure activity, postictal suppression index \> 80%, maximum sustained coherence \> 90% and 5.midictal amplitude \> 180µV

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Sponsor

研究点 (2)

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Optimisation of ECT Based on ASTI vs Narcotrend | 临床试验