Anesthesia, Brugada Syndrome (BrS), Sedation, Ventricular Arrhythmia
Conditions
Keywords
Brugada Syndrome, Anaesthesia, Anesthesia, Perioperative Care, Ventricular Arrhythmias, Cardiac Arrhythmias, Perioperative Risk, Anesthetic Drugs, Propofol, Sodium Channel Blockers, Observational Registry, Multicentre Study
Brief 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.
Interventions
None listed
Sponsors
Hospital Clinic of Barcelona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative anesthetic management strategies in BrS patients | During the anesthesic procedure | 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. |
| Peri-procedural complications and relevant ECG changes | During the anesthesic procedure | To evaluate peri-procedural complications and relevant ECG changes, including dynamic type 1 pattern changes, bradyarrhythmias, supraventricular arrhythmias, haemodynamic instability, fever and electrolyte disturbances. |
| Periprocedural complications | Perioperative | To assess ICU/PACU admission rates, unplanned escalation of care, need for car-dioversion/defibrillation, and peri-procedural ICD management. |
| 30 days outcome | 30 days after the anesthesic procedure | To analyse 30-day outcomes, including ventricular arrhythmic events, mortality and hospital re-admission |
Countries
Spain
Outcome results
None listed