Brugada Syndrome (BrS)PROSP_BRUGANAENCT07655102
Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome
An observational study of Brugada Syndrome (BrS) and Ventricular Arrhythmia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brugada Syndrome (BrS), Ventricular Arrhythmia, Anesthesia
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2026to 20 Dec 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Marina Roger i Coscojuela, Medical Degree, +34689224084, mroger@clinic.cat
Marc Gimenez-Milà, Medical Degree, magimene@clinic.cat
About this study
Official title: 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:
Read more
- 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
- Brugada Syndrome (BrS), Ventricular Arrhythmia, Anesthesia, Sedation
- Keywords
- Brugada Syndrome, Anaesthesia, Anesthesia, Perioperative Care, Ventricular Arrhythmias, Cardiac Arrhythmias, Perioperative Risk, Anesthetic Drugs, Propofol, Sodium Channel Blockers, Observational Registry, Multicentre Study
- Medical subject headings
- Brugada Syndrome, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
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.
Measured: During the anesthesic procedure
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.
Measured: During the anesthesic procedure
Periprocedural complications
To assess ICU/PACU admission rates, unplanned escalation of care, need for car-dioversion/defibrillation, and peri-procedural ICD management.
Measured: Perioperative
30 days outcome
To analyse 30-day outcomes, including ventricular arrhythmic events, mortality and hospital re-admission
Measured: 30 days after the anesthesic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Jul 2026
- Primary completion31 May 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Brugada Syndrome (BrS)Studies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655102
- Sponsor's protocol ID
- HCB/2026/0565
- Acronym
- PROSP_BRUGANAE
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Espinosa A, Ripolles-Melchor J, Brugada R, Campuzano O, Sarquella-Brugada G, Abad-Motos A, Zaballos-Garcia M, Abad-Torrent A, Prieto-Gundin A, Brugada J. Brugada Syndrome: anesthetic considerations and management algorithm. Minerva Anestesiol. 2019 Feb;85(2):173-188. doi: 10.23736/S0375-9393.18.13170-1. Epub 2018 Oct 30.
PubMed 30394071Ojaimi RE, Carteron M, Arnold S, Broux N, Corsia G, Zicarelli JP, Benhamou D. Neuraxial anesthesia for delivery in parturtients with Brugada syndrome: Local anesthetics revisited. J Gynecol Obstet Hum Reprod. 2023 May;52(5):102562. doi: 10.1016/j.jogoh.2023.102562. Epub 2023 Feb 27. No abstract available.
PubMed 36858196Ripley A, Castro J, Gadsden J. Local anesthetics, neuraxial anesthesia, and the Brugada syndrome. J Clin Anesth. 2013 Feb;25(1):78-9. doi: 10.1016/j.jclinane.2012.06.012. Epub 2012 Dec 12. No abstract available.
PubMed 23246496Cole JB, Sattiraju S, Bilden EF, Asinger RW, Bertog SC. Isolated tramadol overdose associated with Brugada ECG pattern. Pacing Clin Electrophysiol. 2012 Aug;35(8):e219-21. doi: 10.1111/j.1540-8159.2010.02924.x. Epub 2010 Oct 7.
PubMed 21039643Rollin A, Maury P, Guilbeau-Frugier C, Brugada J. Transient ST elevation after ketamine intoxication: a new cause of acquired brugada ECG pattern. J Cardiovasc Electrophysiol. 2011 Jan;22(1):91-4. doi: 10.1111/j.1540-8167.2010.01766.x.
PubMed 20384648Cuttone G, Martucci G, Napoli R, Tigano S, Arcadipane A, Pappalardo F, Sanfilippo F. Anesthesiological management of Brugada syndrome patients: A systematic review. Saudi J Anaesth. 2023 Jul-Sep;17(3):394-400. doi: 10.4103/sja.sja_205_23. Epub 2023 Jun 22.
PubMed 37601502Duque M, Santos L, Ribeiro S, Catre D. Anesthesia and Brugada syndrome: a 12-year case series. J Clin Anesth. 2017 Feb;36:168-173. doi: 10.1016/j.jclinane.2016.09.031. Epub 2016 Dec 7.
PubMed 28183560Flamee P, Viaene K, Tosi M, Nogueira Carvalho H, de Asmundis C, Forget P, Poelaert J. Propofol for Induction and Maintenance of Anesthesia in Patients With Brugada Syndrome: A Single-Center, 25-Year, Retrospective Cohort Analysis. Anesth Analg. 2021 Jun 1;132(6):1645-1653. doi: 10.1213/ANE.0000000000005540.
PubMed 33857025Flamee P, Varnavas V, Dewals W, Carvalho H, Cools W, Bhutia JT, Beckers S, Umbrain V, Verborgh C, Forget P, Chierchia GB, Brugada P, Poelaert J, de Asmundis C. Electrocardiographic Effects of Propofol versus Etomidate in Patients with Brugada Syndrome. Anesthesiology. 2020 Mar;132(3):440-451. doi: 10.1097/ALN.0000000000003030.
PubMed 31743136Postema PG, Wolpert C, Amin AS, Probst V, Borggrefe M, Roden DM, Priori SG, Tan HL, Hiraoka M, Brugada J, Wilde AA. Drugs and Brugada syndrome patients: review of the literature, recommendations, and an up-to-date website (www.brugadadrugs.org). Heart Rhythm. 2009 Sep;6(9):1335-41. doi: 10.1016/j.hrthm.2009.07.002. Epub 2009 Jul 8.
PubMed 19716089Borrell-Vega J, Fernandez Font JD, Linares M, Martinez-Palli G, Isabel-Roquero A, Mont L, Brugada J, Arbelo E, Gimenez-Mila M. Eighteen-year analysis of anaesthetic management in Brugada syndrome: The BRUGANAES study. Eur J Anaesthesiol. 2025 May 1;42(5):458-467. doi: 10.1097/EJA.0000000000002146. Epub 2025 Feb 12.
PubMed 39945140Brugada J, Campuzano O, Arbelo E, Sarquella-Brugada G, Brugada R. Present Status of Brugada Syndrome: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Aug 28;72(9):1046-1059. doi: 10.1016/j.jacc.2018.06.037.
PubMed 30139433Brugada P, Brugada J. Right bundle branch block, persistent ST segment elevation and sudden cardiac death: a distinct clinical and electrocardiographic syndrome. A multicenter report. J Am Coll Cardiol. 1992 Nov 15;20(6):1391-6. doi: 10.1016/0735-1097(92)90253-j.
PubMed 1309182
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRUGADA-ANAESTHESIA Registry: Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome
- ClinicalTrials.gov ID
- NCT07655102
- Acronym / sponsor ID
- PROSP_BRUGANAE / HCB/2026/0565
- Conditions
- Brugada Syndrome (BrS), Ventricular Arrhythmia, Anesthesia, Sedation
- Keywords
- Brugada Syndrome, Anaesthesia, Anesthesia, Perioperative Care, Ventricular Arrhythmias, Cardiac Arrhythmias, Perioperative Risk, Anesthetic Drugs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Intraoperative anesthetic management strategies in BrS patients
Time frame: During the anesthesic procedure
Peri-procedural complications and relevant ECG changes
Time frame: During the anesthesic procedure
Periprocedural complications
Time frame: Perioperative
30 days outcome
Time frame: 30 days after the anesthesic procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 30394071Espinosa A, Ripolles-Melchor J, Brugada R, Campuzano O, Sarquella-Brugada G, Abad-Motos A, Zaballos-Garcia M, Abad-Torrent A, Prieto-Gundin A, Brugada J. Brugada Syndrome: anesthetic considerations and management algorithm. Minerva Anestesiol. 2019 Feb;85(2):173-188. doi: 10.23736/S0375-9393.18.13170-1. Epub 2018 Oct 30.
- Background: PubMed 36858196Ojaimi RE, Carteron M, Arnold S, Broux N, Corsia G, Zicarelli JP, Benhamou D. Neuraxial anesthesia for delivery in parturtients with Brugada syndrome: Local anesthetics revisited. J Gynecol Obstet Hum Reprod. 2023 May;52(5):102562. doi: 10.1016/j.jogoh.2023.102562. Epub 2023 Feb 27. No abstract available.
- Background: PubMed 23246496Ripley A, Castro J, Gadsden J. Local anesthetics, neuraxial anesthesia, and the Brugada syndrome. J Clin Anesth. 2013 Feb;25(1):78-9. doi: 10.1016/j.jclinane.2012.06.012. Epub 2012 Dec 12. No abstract available.
- Background: PubMed 21039643Cole JB, Sattiraju S, Bilden EF, Asinger RW, Bertog SC. Isolated tramadol overdose associated with Brugada ECG pattern. Pacing Clin Electrophysiol. 2012 Aug;35(8):e219-21. doi: 10.1111/j.1540-8159.2010.02924.x. Epub 2010 Oct 7.
- Background: PubMed 20384648Rollin A, Maury P, Guilbeau-Frugier C, Brugada J. Transient ST elevation after ketamine intoxication: a new cause of acquired brugada ECG pattern. J Cardiovasc Electrophysiol. 2011 Jan;22(1):91-4. doi: 10.1111/j.1540-8167.2010.01766.x.
- Background: PubMed 37601502Cuttone G, Martucci G, Napoli R, Tigano S, Arcadipane A, Pappalardo F, Sanfilippo F. Anesthesiological management of Brugada syndrome patients: A systematic review. Saudi J Anaesth. 2023 Jul-Sep;17(3):394-400. doi: 10.4103/sja.sja_205_23. Epub 2023 Jun 22.
- Background: PubMed 28183560Duque M, Santos L, Ribeiro S, Catre D. Anesthesia and Brugada syndrome: a 12-year case series. J Clin Anesth. 2017 Feb;36:168-173. doi: 10.1016/j.jclinane.2016.09.031. Epub 2016 Dec 7.
- Background: PubMed 33857025Flamee P, Viaene K, Tosi M, Nogueira Carvalho H, de Asmundis C, Forget P, Poelaert J. Propofol for Induction and Maintenance of Anesthesia in Patients With Brugada Syndrome: A Single-Center, 25-Year, Retrospective Cohort Analysis. Anesth Analg. 2021 Jun 1;132(6):1645-1653. doi: 10.1213/ANE.0000000000005540.
- Background: PubMed 31743136Flamee P, Varnavas V, Dewals W, Carvalho H, Cools W, Bhutia JT, Beckers S, Umbrain V, Verborgh C, Forget P, Chierchia GB, Brugada P, Poelaert J, de Asmundis C. Electrocardiographic Effects of Propofol versus Etomidate in Patients with Brugada Syndrome. Anesthesiology. 2020 Mar;132(3):440-451. doi: 10.1097/ALN.0000000000003030.
- Background: PubMed 19716089Postema PG, Wolpert C, Amin AS, Probst V, Borggrefe M, Roden DM, Priori SG, Tan HL, Hiraoka M, Brugada J, Wilde AA. Drugs and Brugada syndrome patients: review of the literature, recommendations, and an up-to-date website (www.brugadadrugs.org). Heart Rhythm. 2009 Sep;6(9):1335-41. doi: 10.1016/j.hrthm.2009.07.002. Epub 2009 Jul 8.
- Background: PubMed 39945140Borrell-Vega J, Fernandez Font JD, Linares M, Martinez-Palli G, Isabel-Roquero A, Mont L, Brugada J, Arbelo E, Gimenez-Mila M. Eighteen-year analysis of anaesthetic management in Brugada syndrome: The BRUGANAES study. Eur J Anaesthesiol. 2025 May 1;42(5):458-467. doi: 10.1097/EJA.0000000000002146. Epub 2025 Feb 12.
- Background: PubMed 30139433Brugada J, Campuzano O, Arbelo E, Sarquella-Brugada G, Brugada R. Present Status of Brugada Syndrome: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Aug 28;72(9):1046-1059. doi: 10.1016/j.jacc.2018.06.037.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome (BrS) and Ventricular Arrhythmia, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac arrhytmia from the start of anaesthesia/sedation until 24 hours after the procedure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07655102, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.