Arrhythmias Ventricular
Conditions
Keywords
lidocaine, amiodarone
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.
Interventions
DRUGAntiarrythmic 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.
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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowering the level of consciousness. | 1 hour | glasgow \< 15 |
| HR increase | 1 hour | HR increase\> 20 bpm. |
| The appearance of polymorphic TV. | 1 hour | polymorphic TV. |
| Signs of pulmonary congestion | 1 hour | dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry. |
| Signs of peripheral hypoperfusion and shock | 1 hour | hypoperfusion and shock |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time required for reversal | 1 hour | sinusal rhythm |
| effectiveness of reversal | 1 hour | sinusal rhythm |
Countries
Brazil
Contacts
Primary ContactAlexandre Soeiro, MD
Outcome results
None listed