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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03105245




Registration number
NCT03105245
Ethics application status
Date submitted
27/02/2017
Date registered
7/04/2017
Date last updated
30/03/2023

Titles & IDs
Public title
Understanding How Anaesthesia Affects ECT Outcomes
Scientific title
Understanding How Anaesthesia Affects ECT Outcomes
Secondary ID [1] 0 0
HREC16952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Active Comparator: Short time interval + Normal ventilation -

Active Comparator: Short time interval + Hyperventilation -

Active Comparator: Long time interval + Normal ventilation -

Active Comparator: Long time interval + Hyperventilation -


Other interventions: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
Timepoint [1] 0 0
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

Eligibility
Key inclusion criteria
- Patients treated with a course of ECT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of non-standard anaesthetic agents in ECT (e.g. ketamine)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2019
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wesley Hospital Kogarah - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wesley Mission
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03105245
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MBBS
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03105245