PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT (AMIOLIDO-VT)

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 4

Conditions: Arrhythmias Ventricular

Treatments: Drug: Antiarrythmic Drugs; Drug: Antiarrhythmic drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT03299517

PSInCor-AMIOLIDO-VT

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 2 patient groups

lidocaine

Experimental group

Description:

Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).

Treatment:

Drug: Antiarrythmic Drugs

amiodarone

Experimental group

Description:

Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)

Treatment:

Drug: Antiarrhythmic drugs