이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 12일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

연구 유형

관찰

등록 (추정된)

200

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

스페인
- Barcelona
  - Barcelona, Barcelona, 스페인, 08036
    - Hospital Clinic De Barcelona
    - 연락하다:
      
      Marina Roger i Coscojuela, Medical Degree
      
      전화번호: +34689224084
      
      이메일: mroger@clinic.cat
    - 연락하다:
      
      Marc Gimenez-Milà, Medical Degree
      
      이메일: magimene@clinic.cat

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Incidence of cardiac arrhytmia from the start of anaesthesia/sedation until 24 hours after the procedure 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Intraoperative anesthetic management strategies in BrS patients 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospital Clinic of Barcelona

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 20일

기본 완료 (추정된)

2028년 5월 31일

연구 완료 (추정된)

2028년 12월 20일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출