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

Hospital Clinic of Barcelona200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Brugada Syndrome (BrS)Ventricular Arrhythmia Anesthesia Sedation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Patients should match all the inclusion criteria to be entered for data collection: * Documented type 1 Brugada ECG pattern (spontaneous, fever-related, or induced by sodium-channel blocker challenge/other recognised provocation test) with a diagnosis considered compatible with Brugada syndrome by the treating cardiology team. * Undergoing general anaesthesia, monitored sedation, loco-regional anaesthesia for any surgical, diagnostic, interventional, obstetric or other non-surgical procedure (including epidural analgesia for labour and sedation for endoscopy). Patients with one or more exclusion criteria will not be included for data collection and analysis: * No documented type 1 Brugada ECG pattern, uncertain diagnosis without sufficient supporting data. * Refusal to participate in the study.

Outcomes

Primary Outcomes

Incidence of cardiac arrhytmia from the start of anaesthesia/sedation until 24 hours after the procedure

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.

Time frame: 24 hours

Secondary Outcomes

Intraoperative anesthetic management strategies in BrS patients

Intraoperative anesthetic management strategies in BrS patients, including use of general anaesthesia, monitored sedation, neuraxial and regional techniques across surgical, diagnostic, obstetric and non-surgical settings.

Time frame: During the anesthesic procedure

Peri-procedural complications and relevant ECG changes

To evaluate peri-procedural complications and relevant ECG changes, including dynamic type 1 pattern changes, bradyarrhythmias, supraventricular arrhythmias, haemodynamic instability, fever and electrolyte disturbances.

Time frame: During the anesthesic procedure

Periprocedural complications

To assess ICU/PACU admission rates, unplanned escalation of care, need for car-dioversion/defibrillation, and peri-procedural ICD management.

Time frame: Perioperative

30 days outcome

To analyse 30-day outcomes, including ventricular arrhythmic events, mortality and hospital re-admission

Time frame: 30 days after the anesthesic procedure