Optimisation of ECT Based on ASTI vs Narcotrend

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Procedure: Narcotrend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-3 Age: 18 -90 years Signed informed consent Severe depressive disorder Exclusion Criteria: ASA >3 Age < 18 or > 90 denial of the patient Impossibility to fix Narcotrend electrodes Patients unable to consent Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ASTI<br>ECT guided with ASTi 2-4 min | |
| Active Comparator: Narcotrend<br>ECT guided with ECT | Procedure: Narcotrend<br>* ECT stimulation within an anaesthesia depth range of 41-64<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Convulsion Quality | 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 | One hour |