Understanding How Anaesthesia Affects ECT Outcomes

NCT ID: NCT03105245

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-03-15

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will receive all four treatment conditions in randomly allocated sequence during their ECT course. That is, participants will receive either short or long anaesthetic-ECT stimulus time interval treatments, and normal or hyperventilation treatments - this results in four possible combinations, which individual participants will cycle through in random order during their ECT course (e.g. short-hyperventilation, long-normal ventilation, short-normal ventilation, long-hyperventilation).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Both participants and the outcome assessor (analysing EEGs) will be blinded.

Study Groups

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Short time interval + Normal ventilation

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Intervention Type OTHER

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Short time interval + Hyperventilation

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Intervention Type OTHER

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Long time interval + Normal ventilation

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Intervention Type OTHER

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Long time interval + Hyperventilation

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Intervention Type OTHER

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Interventions

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Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients treated with a course of ECT

Exclusion Criteria

* Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wesley Mission

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen Loo, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of New South Wales

Locations

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Wesley Hospital Kogarah

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC16952

Identifier Type: -

Identifier Source: org_study_id

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