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

Sponsored by Hospital Clinic of Barcelona

NCT ID
NCT07655102
Target Enrollment
200 participants
Start Date
2026-07-20
Est. Completion
2028-12-20

About This Study

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.

Conditions Studied

Brugada Syndrome (BrS)Ventricular ArrhythmiaAnesthesiaSedation

Eligibility

Healthy Volunteers:No
View full eligibility 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.

Study Locations (1)

Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source