PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

University of Sao Paulo General Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Arrhythmias Ventricular

Interventions

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.

Antiarrhythmic drugsDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto do Coração - HMFMUSP

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Signs of peripheral hypoperfusion and shock

hypoperfusion and shock

Time frame: 1 hour

Signs of pulmonary congestion

dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.

Time frame: 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).

Time frame: 1 hour

HR increase

HR increase\> 20 bpm.

Time frame: 1 hour

The appearance of polymorphic TV.

polymorphic TV.

Time frame: 1 hour

Lowering the level of consciousness.

glasgow \< 15

Time frame: 1 hour

Secondary Outcomes

effectiveness of reversal

sinusal rhythm

Time frame: 1 hour

time required for reversal

sinusal rhythm

Time frame: 1 hour

Central Contacts

Alexandre Soeiro, MD

CONTACT

1126615299 alexandre.soeiro@bol.com.br

Data from ClinicalTrials.gov

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