Optimisation of ECT Based on ASTI vs Narcotrend

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT04657575
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-03-01
• Status Verified: 2022-04
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Convulsion Quality	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

Trial Locations

Locations (1)

Medical University Hospital Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria