PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2022-08-02

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.

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Detailed Description

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Conditions

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Arrhythmias Ventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Antiarrythmic Drugs

Intervention Type DRUG

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.

amiodarone

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

Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)

Group Type EXPERIMENTAL

Antiarrhythmic drugs

Intervention Type DRUG

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.

Interventions

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Antiarrythmic Drugs

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.

Intervention Type DRUG

Antiarrhythmic drugs

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.

Intervention Type DRUG

Other Intervention Names

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lidocaine amiodarone

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No