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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine | Experimental | Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes). |
|
| amiodarone | Experimental | Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiarrythmic Drugs | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Signs of peripheral hypoperfusion and shock | hypoperfusion and shock | 1 hour |
| Signs of pulmonary congestion | dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry. | 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). | 1 hour |
| HR increase | HR increase> 20 bpm. | 1 hour |
| The appearance of polymorphic TV. | polymorphic TV. | 1 hour |
| Lowering the level of consciousness. | glasgow < 15 | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness of reversal | sinusal rhythm | 1 hour |
| time required for reversal | sinusal rhythm | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Soeiro, MD | Contact | 1126615299 | alexandre.soeiro@bol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Soeiro, MD | Unidade ClÃnica de Emergência | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração - HMFMUSP | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12372573 | Result | Somberg JC, Bailin SJ, Haffajee CI, Paladino WP, Kerin NZ, Bridges D, Timar S, Molnar J; Amio-Aqueous Investigators. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002 Oct 15;90(8):853-9. doi: 10.1016/s0002-9149(02)02707-8. | |
| 26472995 | Result |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000889 | Anti-Arrhythmia Agents |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Antiarrhythmic drugs | 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. |
|
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| Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. |
| Aniline Compounds |
| D000588 | Amines |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |