PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

Study Overview
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Brief Summary
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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.

Official Title
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PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM

Conditions
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Arrhythmias Ventricular

Intervention / Treatment
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* Drug: Antiarrythmic Drugs
* Drug: Antiarrhythmic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine<br>Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes). | Drug: Antiarrythmic Drugs<br>* Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.<br>* Other names: lidocaine;|
| Experimental: amiodarone<br>Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes) | Drug: Antiarrhythmic drugs<br>* Patient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.<br>* Other names: amiodarone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of peripheral hypoperfusion and shock | hypoperfusion and shock | 1 hour | 
| Signs of pulmonary congestion | dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry. | 1 hour | 
| Severe hypotension | 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). | 1 hour | 
| HR increase | HR increase> 20 bpm. | 1 hour | 
| The appearance of polymorphic TV. | polymorphic TV. | 1 hour | 
| Lowering the level of consciousness. | glasgow < 15 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of reversal | sinusal rhythm | 1 hour | 
| time required for reversal | sinusal rhythm | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, amiodarone