Propofol and etomidate. Are they also safe for patients with Brugada-Syndrome?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000584-25-BE

Enrollment

Registered

2012-03-06

Start date

2012-03-29

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suspected to have Brugada Syndrome

Interventions

Trade Name: Diprivan Product Name: Propofol Product Code: BE133752 Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: PROPOFOL CAS Number: 2078-54-8 Current Sponsor code: Dipriv

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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)	—

Measure

Time frame

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. 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

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Belgium

Contacts

Public ContactAnaesthesia Department

UZBrussel

panagiotis.flamee@me.com003224778926

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026