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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospital Clinic of Barcelona

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

No documented type 1 Brugada ECG pattern, uncertain diagnosis without sufficient supporting data.

Refusal to participate in the study.

Trial population

The study population will consist of adult patients with a confirmed diagnosis of Brugada Syndrome receiving care at participating tertiary and secondary hospitals. Patients will be identified through preoperative anaesthesia assessments, hospital admissions, and operating room schedules. The registry will include consecutive patients undergoing any type of anaesthetic procedure (general, locoregional, or sedation) for surgical or non-surgical interventions as part of routine clinical care. Participating centres are expected to include institutions with experience in the perioperative management of cardiac patients, ensuring representation of real-world clinical practice across different healthcare settings.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Brugada Syndrome Patients Undergoing Anaesthesia

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

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