Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome

Condition(s) studied

Study summary

The goal of this observational study is to evaluate the perioperative risk of malignant ventricular arrhythmias in adult patients diagnosed with Brugada Syndrome undergoing anaesthetic procedures. Brugada Syndrome is a rare inherited cardiac condition associated with an increased risk of life-threatening arrhythmias, and perioperative management remains challenging due to limited high-quality evidence.

The main questions it aims to answer are:

* What is the incidence of malignant ventricular arrhythmias during anaesthesia and up to 30 days after the procedure?
* Are anaesthetic drugs traditionally considered "non-recommended" associated with an increased risk of perioperative arrhythmic events?

Researchers will also explore the relative contribution of anaesthetic drugs versus perioperative physiological factors (e.g., haemodynamic changes, fever, bradycardia) in triggering arrhythmias.

Participants will:

* Undergo anaesthetic procedures (general, locoregional, or sedation) as part of routine clinical care
* Have clinical data collected prospectively from electronic medical records during the perioperative period
* Be followed for 30 days after the procedure to assess outcomes, including arrhythmias, complications, ICU admission, and mortality

This is a multicentre, prospective observational registry, and no additional interventions or changes to standard clinical practice will be performed.

Eligibility

Primary outcome measure(s)

• Incidence of cardiac arrhytmia from the start of anaesthesia/sedation until 24 hours after the procedure — 24 hours
  To determine the incidence of sustained ventricular tachycardia, ventricular fibrillation, arrhythmic cardiac arrest, aborted sudden cardiac death, or appropriate ICD therapy for ventricular arrhythmia from the start of anaesthesia/sedation until 24 hours after the procedure.

Trial sites (1)

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