PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

Phase 4

• Conditions: Arrhythmias Ventricular
• Interventions: Drug: Antiarrhythmic drugs; Drug: Antiarrythmic Drugs

• Registration Number: NCT03299517
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24
• Primary Completion: 2019-08-02
• Study Completion: 2022-08-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
amiodarone	Antiarrhythmic drugs	Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)
lidocaine	Antiarrythmic Drugs	Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).

Primary Outcome Measures

Name	Time	Method
HR increase	1 hour	HR increase\> 20 bpm.
Signs of peripheral hypoperfusion and shock	1 hour	hypoperfusion and shock
Signs of pulmonary congestion	1 hour	dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Severe hypotension	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.	1 hour	glasgow \< 15
The appearance of polymorphic TV.	1 hour	polymorphic TV.

Secondary Outcome Measures

Name	Time	Method
effectiveness of reversal	1 hour	sinusal rhythm
time required for reversal	1 hour	sinusal rhythm

Trial Locations

Locations (1)

Instituto do Coração - HMFMUSP; 🇧🇷 São Paulo, SP, Brazil