BRUGADA-ANAESTHESIA Registry: Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.