None listed
Conditions
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.
Interventions
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
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.
Sponsors
Departments of Anaesthesia, Cardiology - Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who are scheduled for elective or semi- elective ventricular tachycardia ablation under general anaesthesia
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.
Outcome results
None listed