Propofol and etomidate. Are they also safe for patients with Brugada-Syndrome?
Phase 1
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Patients suspected to have Brugada Syndrome
- Registration Number
- EUCTR2012-000584-25-BE
- Lead Sponsor
- ZBrussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
All paediatric and adult patients that have been screened for BrS and were found positive before or after the Ajmaline-test are included.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Exclusion Criteria
Patients with a known allergy for soya or egg are excluded from the study.
Patients with a supressed immune-status are excluded from the study.
Patients with a recent transient ischemic attack or cerebrovascular accident will be excluded from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to investigate whether commonly used hypnotic agents, propofol and etomidate, are also safe for patients with BrS.;Secondary Objective: Investigate difference in safety profile between propofol and etomidate;Primary end point(s): ST segment elevation of more than or equal to 2mm.<br>30% prolongation of the QRS, or induction of ventricular arrhythmias, or any other rhythm disturbance that could compromise the safety of our patient.;Timepoint(s) of evaluation of this end point: 30minutes of continuous 12-lead ECG registration, starting from induction of anaesthesia (T0=start of infusion of induction drug)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: N/A