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Trial registered on ANZCTR
Registration number
ACTRN12623000825651
Ethics application status
Approved
Date submitted
6/07/2023
Date registered
1/08/2023
Date last updated
1/08/2023
Date data sharing statement initially provided
1/08/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Effect of Volatile Versus Total Intravenous Anaesthesia (TIVA) on the Inducibility of Tachyarrhythmias During Ventricluar Tachycardia (VT) Ablation Procedures
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Scientific title
The Effect of Volatile Versus Total Intravenous Anaesthesia on the Inducibility of Tachyarrhythmias During Ventricular Tachycardia Ablation procedures
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Secondary ID [1]
310065
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ventricular tachycardia
330604
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Anaesthesia
330605
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Condition category
Condition code
Anaesthesiology
327443
327443
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0
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Anaesthetics
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Cardiovascular
327444
327444
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Volatile group: Continuous inhaled sevoflurane (titrated to adequate end-tidal concentrations) for maintenance of general anaesthesia for at least the duration of the VT induction (5-10 minutes). Age-based MAC values >0.6 will generally be considered adequate. However, the required level will be titrated based on processed EEG-monitoring.
TIVA group: Continuous intravenous propofol (using a target-controlled infusion protocol) for maintenance of general anaesthesia for at least the duration of the VT induction. Using a pre-programmed Schnider model, propofol infusion will generally be aiming for an effect site concentration between 2 and 5 mcg/ml. The required level will be titrated based on processed EEG-monitoring.
As part of the cross-over design, patients will be switched from one type of medication to the other during the procedure, after the first VT induction. There will be a 30-minute wash out period in between. At least one of the maintenance medication will be continuously administered at any point in time to keep the patient anaesthetised. MAC values, infusion rates and processed EEG values (BIS) will be collected during the VT inductions. The total duration of the measurements (including wash out) will be around 45 minutes. The duration of the entire general anaesthetic depends on the duration of the VT ablation procedure, but typically varies between 2 and 6 hours.
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Intervention code [1]
326472
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Treatment: Drugs
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Comparator / control treatment
Participants are their own control and will be exposed to both interventions. However, as TIVA is more commonly used, this can be considered the 'reference' group.
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Control group
Active
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Outcomes
Primary outcome [1]
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VT inducibility, defined as whether or not VT could be induced. This is monitored using multi-lead ECG.
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Assessment method [1]
335302
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Timepoint [1]
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During VT ablation procedure at two set timepoints: the first once stable anaesthesia is established using the initial treatment and all required intracardiac catheters are in position, and the second 30 minutes after switching the type of anaesthetic agent.
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Secondary outcome [1]
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Level of induction required, as assessed by ECG
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Assessment method [1]
423833
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Timepoint [1]
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During VT induction procedure
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Secondary outcome [2]
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Modes of induction required. Data will be collected from the electrophysiology reporting system.
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Assessment method [2]
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Timepoint [2]
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During VT induction procedure
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Secondary outcome [3]
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Quality of recovery on post-procedure day 1, as assessed by the Quality of Recovery 15 questionnaire
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Assessment method [3]
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Timepoint [3]
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Post-procedure day 1
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Secondary outcome [4]
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Long-term ablation success rate. These data will be collected from medical records of routine follow-up visits with the cardiologist
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Assessment method [4]
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Timepoint [4]
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Post-procedural clinic visit, which normally takes place 4-6 weeks after the procedure.
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Eligibility
Key inclusion criteria
Patients who are scheduled for elective or semi- elective ventricular tachycardia ablation under general anaesthesia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who are deemed unfit for general anaesthesia, and those who are haemodynamically unstable before the start of the procedure will be excluded.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
5
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Departments of Anaesthesia, Cardiology - Westmead Hospital
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Address [1]
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Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Departments of Anaesthesia, Cardiology - Westmead Hospital
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Address
Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145
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Country
Australia
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Secondary sponsor category [1]
316277
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None
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Name [1]
316277
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None
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Address [1]
316277
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None
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Country [1]
316277
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313353
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
313353
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Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
313353
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Approval date [1]
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15/02/2023
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Ethics approval number [1]
313353
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Summary
Brief summary
This is a pilot RCT to test the hypothesis that sevoflurane use for maintenance of general anaesthesia will result in reduced inducibility of ventricular tachyarrhythmias when compared to maintenance with propofol. The study is conducted in adult patients (>18 years) who are scheduled for elective or semi- elective ventricular tachycardia ablation under general anaesthesia at 2 hospitals in Sydney. Patients will receive both types of anaesthesia for maintenance during 2 subsequent periods of time (in random order, and with a wash-out period in between). During each period, a standardised VT induction protocol will be performed. The primary outcome of the study is VT inducibility. Secondary outcomes include modes of induction required, quality of recovery on post-procedure day 1, and long-term ablation success rate.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Stefan Dieleman
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Address
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Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 288906447
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Stefan Dieleman
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Address
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Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 288906447
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Stefan Dieleman
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Address
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Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 288906447
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Fax
127852
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Email
127852
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19618
Study protocol
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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