Back to resultsUnderstanding How Anaesthesia Affects ECT Outcomes
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring electroconvulsive therapy, anaesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients treated with a course of ECT
Exclusion Criteria:
- Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
Sites / Locations
- Wesley Hospital Kogarah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Short time interval + Normal ventilation
Short time interval + Hyperventilation
Long time interval + Normal ventilation
Long time interval + Hyperventilation
Arm Description
Outcomes
Primary Outcome Measures
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03105245
First Posted
February 27, 2017
Last Updated
March 28, 2023
Sponsor
The University of New South Wales
Collaborators
Wesley Mission
1. Study Identification
Unique Protocol Identification Number
NCT03105245
Brief Title
Understanding How Anaesthesia Affects ECT Outcomes
Official Title
Understanding How Anaesthesia Affects ECT Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
Collaborators
Wesley Mission
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
electroconvulsive therapy, anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
ParticipantOutcomes Assessor
Masking Description
Both participants and the outcome assessor (analysing EEGs) will be blinded.
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short time interval + Normal ventilation
Arm Type
Active Comparator
Arm Title
Short time interval + Hyperventilation
Arm Type
Active Comparator
Arm Title
Long time interval + Normal ventilation
Arm Type
Active Comparator
Arm Title
Long time interval + Hyperventilation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
Intervention Description
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
Primary Outcome Measure Information:
Title
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
Description
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated with a course of ECT
Exclusion Criteria:
Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MBBS
Organizational Affiliation
The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesley Hospital Kogarah
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Understanding How Anaesthesia Affects ECT Outcomes
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