Optimisation of ECT Based on ASTI vs Narcotrend

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657575
• Other study ID #: ECT: ASTI vs Narcotrend
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2022
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• Narcotrend
ECT stimulation within an anaesthesia depth range of 41-64

Locations

Country	Name	City	State
Austria	Medical University Hospital Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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