Sodium Bicarbonate for Acute Peripheral Vertigo

National Taiwan University

Status: Enrolling

Conditions: Peripheral Vertigo

Treatments: Drug: Sodium Bicarbonate; Drug: Diphenhydramine + Sodium Bicarbonate; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT05676216

202209092MIND

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 3 patient groups

Diphenhydramine

Active Comparator group

Description:

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

Treatment:

Drug: Diphenhydramine

Sodium Bicarbonate

Experimental group

Description:

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping

Treatment:

Drug: Sodium Bicarbonate

Diphenhydramine with Sodium Bicarbonate

Experimental group

Description:

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push

Treatment:

Drug: Diphenhydramine + Sodium Bicarbonate