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

June 12, 2026 updated by: Hospital Clinic of Barcelona

BRUGADA-ANAESTHESIA Registry: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
        • Contact:
          • Marina Roger i Coscojuela, Medical Degree
          • Phone Number: +34689224084
          • Email: mroger@clinic.cat
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Brugada Syndrome Patients Undergoing Anaesthesia
Adult patients (≥18 years) with a confirmed diagnosis of Brugada Syndrome undergoing anaesthetic procedures (general, locoregional, or sedation) for surgical or non-surgical interventions. This is an observational cohort with no assigned interventions. Anaesthetic management, including the use of specific drugs (e.g., propofol, local anaesthetics, ketamine), will be performed according to routine clinical practice. Participants will be followed during the perioperative period and up to 30 days after the procedure to assess the occurrence of malignant ventricular arrhythmias and other clinical outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the anesthesic procedure
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.
During the anesthesic procedure
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.
Perioperative
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
30 days after the anesthesic procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 20, 2028

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2026/0565

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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