DExmEdetomidine Sedation Versus Propofol SEDATION FOR Catheter ABLATION of Atrial Fibrillation Under a Cardiologist Supervision: A Randomized Controlled Pilot STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint)
研究概览
简要总结
Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. However, due to the depressive effect of Propofol on the respiratory system, this regimen is not without risk. Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak effect on the respiratory system. The pharmacological profile of Dexmedetomidine may be advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.
详细描述
Atrial fibrillation (AF) is the most common arrhythmia. In symptomatic patients, electroanatomic mapping aided catheter ablation (CA) is an established therapeutic option. The intervention may last several hours, during which patients are required to lie as still as possible, as inadequate patient movements disturb the electroanatomic map, prolong the intervention and increase its complication risks. Therefore patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. Despite its wide use, this regimen is not without risk, as Propofol has a pronounced depressive effect on the respiratory system.
Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak respiratory depression. By reducing sympathetic activity it also reduces the stress response to an intervention. For these reasons, Dexmedetomidine is commonly used in intensive care units, where it has been shown to be well tolerated. Consequently, its range of application has been increasingly widened and good experience has been made with its use in transfemoral valve replacement procedures or gastroenterological interventions.
The pharmacological profile of dexmedetomidine may be also advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Informed consent as documented by signature
- •Catheter ablation of atrial fibrillation at the Department of Cardiology, Inselspital Bern
排除标准
- •Contraindication to sedation by the electrophysiologist
- •Contraindications to either propofol or dexmedetomidine sedation
- •Contraindication for targeted controlled propofol infusion (BMI > 35)
- •American Society of Anesthesiologists (ASA) classification > III
- •Advanced heart block (second or third degree), if no pacemaker or internal cardioverter defibrillator is implanted
- •Arterial hypotension (mean < 80 mmHg)
- •Severe heart failure (LVEF ≤ 30%)
- •Indication for general anaesthesia
- •Pregnant or breast-feeding women
研究组 & 干预措施
Propofol
Active agent: Propofolum (2,6-Diisopropylphenol). Route of administration: intravenous
干预措施: Propofol (Drug)
Dexmedetomidine
Active agent: Dexmedetomidinum ut Dexmedetomidini hydrochloridum. Route of administration: intravenous
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint)
时间窗: within 24 hours after completion of procedure
* Number of participants with sustained bradycardia necessitating cardiac pacing * Number of participants with Hypercapnia, defined as rise of transcutaneously measured carbon dioxide levels (tcCO2) \> 20mmHg * Number of participants with Oxygen desaturation (\<90%) necessitating assisted ventilation or further airway management in any form (including chin lift, oropharyngeal airway, bag, and mask ventilation or intubation) * Number of participants with Hypotension necessitating termination of sedation or vasopressor administration * Number of participants with necessity of termination or change of sedation protocol * Number of participants with aborted procedure due to sedation issues
次要结局
- Patient satisfaction: Patient Satisfaction with Sedation Instrument (PSSI) [score](within 24 hours after completion of procedure)
- Opiod dose(from start until end of ablation procedure)
- Arrhythmia inducibility(from start until end of ablation procedure)
- Cardiologist satisfaction: Clinician Satisfaction with Sedation Instrument (CSSI) [score](within 24 hours after completion of procedure)
- Incidence of Sedation-Emergent Adverse Events (Individual Safety Endpoints)(within 24 hours after completion of procedure)
- Other complications(from start until end of ablation procedure)
- Procedure duration(from start until end of ablation procedure)
- Fluoroscopy time(from start until end of ablation procedure)
- General sedation efficacy: occurrence and number of shiftings(from start until end of ablation procedure)
- Sedation depth(from start until end of ablation procedure)
- Heart rate(from start until end of ablation procedure)
- Refractory period(from start until end of ablation procedure)
- Wenckebach point(from start until end of ablation procedure)
- Blood pressure(from start until end of ablation procedure)