Trial Review

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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
Scientific title
The Effect of Volatile Versus Total Intravenous Anaesthesia on the Inducibility of Tachyarrhythmias During Ventricular Tachycardia Ablation procedures
Secondary ID [1] 310065 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular tachycardia 330604 0
Anaesthesia 330605 0
Condition category
Condition code
Anaesthesiology 327443 327443 0 0
Anaesthetics
Cardiovascular 327444 327444 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326472 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 335302 0
VT inducibility, defined as whether or not VT could be induced. This is monitored using multi-lead ECG.
Timepoint [1] 335302 0
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.
Secondary outcome [1] 423833 0
Level of induction required, as assessed by ECG
Timepoint [1] 423833 0
During VT induction procedure
Secondary outcome [2] 424155 0
Modes of induction required. Data will be collected from the electrophysiology reporting system.
Timepoint [2] 424155 0
During VT induction procedure
Secondary outcome [3] 424156 0
Quality of recovery on post-procedure day 1, as assessed by the Quality of Recovery 15 questionnaire
Timepoint [3] 424156 0
Post-procedure day 1
Secondary outcome [4] 424157 0
Long-term ablation success rate. These data will be collected from medical records of routine follow-up visits with the cardiologist
Timepoint [4] 424157 0
Post-procedural clinic visit, which normally takes place 4-6 weeks after the procedure.

Eligibility
Key inclusion criteria
Patients who are scheduled for elective or semi- elective ventricular tachycardia ablation under general anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314233 0
Hospital
Name [1] 314233 0
Departments of Anaesthesia, Cardiology - Westmead Hospital
Country [1] 314233 0
Australia
Primary sponsor type
Hospital
Name
Departments of Anaesthesia, Cardiology - Westmead Hospital
Address
Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 316277 0
None
Name [1] 316277 0
None
Address [1] 316277 0
None
Country [1] 316277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313353 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313353 0
Cnr Hawkesbury & Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 313353 0
Australia
Date submitted for ethics approval [1] 313353 0
Approval date [1] 313353 0
15/02/2023
Ethics approval number [1] 313353 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127850 0
A/Prof Stefan Dieleman
Address 127850 0
Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 127850 0
Australia
Phone 127850 0
+61 288906447
Fax 127850 0
Email 127850 0
jan.dieleman@health.nsw.gov.au
Contact person for public queries
Name 127851 0
A/Prof Stefan Dieleman
Address 127851 0
Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 127851 0
Australia
Phone 127851 0
+61 288906447
Fax 127851 0
Email 127851 0
jan.dieleman@health.nsw.gov.au
Contact person for scientific queries
Name 127852 0
A/Prof Stefan Dieleman
Address 127852 0
Dept of Anaesthesia, Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 127852 0
Australia
Phone 127852 0
+61 288906447
Fax 127852 0
Email 127852 0
jan.dieleman@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19618Study protocol  jan.dieleman@health.nsw.gov.au



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.