Understanding How Anaesthesia Affects ECT Outcomes

March 28, 2023 updated by: Colleen Loo, The University of New South Wales
This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to examine how the time interval between administration of anaesthetic agent and ECT stimulus delivery impacts upon measures of EEG quality (seizure quality).

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2217
        • Wesley Hospital Kogarah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients treated with a course of ECT

Exclusion Criteria:

  • Use of non-standard anaesthetic agents in ECT (e.g. ketamine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short time interval + Normal ventilation
Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
Active Comparator: Short time interval + Hyperventilation
Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
Active Comparator: Long time interval + Normal ventilation
Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
Active Comparator: Long time interval + Hyperventilation
Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
Time Frame: Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants
EEG quality will be rated manually for each ECT treatment undertaken by a participant until the conclusion of their ECT course. This rating will be done using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al - low dose lignocaine added to propofol does not attenuate the response to electroconvulsive therapy; Journal of Affective Disorders, 2010; 126: 330-333
Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Collaborators

Wesley Mission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

April 2, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC16952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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