PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HR increase
研究概览
简要总结
Introduction: Recent studies have suggested that other medications may be superior to amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized comparison with lidocaine has not yet been described.
Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone versus lidocaine in patients with stable ventricular tachycardias.
Methodology: For this, a unicentric, randomized and prospective study will be carried out, in which the two drugs will be administered in a comparative manner. Hospital data (test results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed for safety and effectiveness.
Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and reversion of stable ventricular tachycardias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •Adult men and women> 18 years old
- •Presence of sustained ventricular tachycardia with HR> 120 bpm
- •Systolic blood pressure> 90 mmHg
- •No signs of poor peripheral perfusion
- •Absence of dyspnea
- •Absence of severe angina
- •Signed consent form
排除标准
- •Pregnancy
- •Hemodynamic instability
- •Body mass index greater than 40 kg / m2
- •Use of intravenous amiodarone or lidocaine in the last 24 hours
- •Acute coronary syndrome
- •Presence of tachycardia with irregular or supraventricular RR
- •Contraindications to study drugs
研究组 & 干预措施
lidocaine
Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes).
Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).
干预措施: Antiarrythmic Drugs (Drug)
amiodarone
Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes)
Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)
干预措施: Antiarrhythmic drugs (Drug)
结局指标
主要结局
HR increase
时间窗: 1 hour
HR increase\> 20 bpm.
Signs of peripheral hypoperfusion and shock
时间窗: 1 hour
hypoperfusion and shock
Signs of pulmonary congestion
时间窗: 1 hour
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Severe hypotension
时间窗: 1 hour
systolic blood pressure \<70 mmHg if the previous one is \<100 mmHg or systolic blood pressure \<80 mmHg if the previous one is \> 100 mmHg).
Lowering the level of consciousness.
时间窗: 1 hour
glasgow \< 15
The appearance of polymorphic TV.
时间窗: 1 hour
polymorphic TV.
次要结局
- effectiveness of reversal(1 hour)
- time required for reversal(1 hour)