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NCT Number: NCT07655102

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

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.

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Key information

Conditions

Brugada Syndrome (BrS) Anesthesia Arrhythmias, Cardiac Brugada Syndrome Cardiac Conduction System Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sedation Ventricular Arrhythmia

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Intraoperative anesthetic management strategies in BrS patients

    Time frame: 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.

  2. Peri-procedural complications and relevant ECG changes

    Time frame: 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.

  3. Periprocedural complications

    Time frame: Perioperative

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

  4. 30 days outcome

    Time frame: 30 days after the anesthesic procedure

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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: PROSP_BRUGANAE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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