Sodium Bicarbonate for Acute Peripheral Vertigo

Study Overview
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Brief Summary
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Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED. Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling. Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication. This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.

Official Title
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Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial

Conditions
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Peripheral Vertigo

Intervention / Treatment
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* Drug: Diphenhydramine
* Drug: Sodium Bicarbonate
* Drug: Diphenhydramine + Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute onset vertigo Exclusion Criteria: Pregnancy First vertigo episode over 24 hours Using any anti-vertigo medicine after onset Drug allergy to Sodium bicarbonate or Diphenhydramine Diagnosed with central vertigo Heart failure NYHA class >1 Chronic kidney disease (CKD) stage ≥ 3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diphenhydramine<br>Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping | Drug: Diphenhydramine<br>* Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department<br>|
| Experimental: Sodium Bicarbonate<br>Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping | Drug: Sodium Bicarbonate<br>* Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department<br>|
| Experimental: Diphenhydramine with Sodium Bicarbonate<br>Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push | Drug: Diphenhydramine + Sodium Bicarbonate<br>* Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in vertigo intensity | Reduction in Vertigo Visual Analog Scale (VAS 0 10, higher scores mean higher intensity) from baseline | Baseline and 60 minutes after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in nausea intensity | Reduction in Nausea Visual Analog Scale (VAS 0 10, higher scores mean higher intensity) from baseline | Baseline and 60 minutes after drug administration | 
| Improvement of ambulatory ability | Change in objective ambulatory ability (score 1 4, higher scores mean a worse outcome) from baseline | Baseline and 60 minutes after drug administration | 
| Lethargy | Lethargy score (score 1 4, 1 indicates no lethargy and 4 indicates very lethargy) | 60 minutes after drug administration | 
| Emergency Department staying time | From patients admit to Emergency Department until patients discharge (up to 24 hours) | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium Bicarbonate, Diphenhydramine