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Sodium Bicarbonate for Acute Peripheral Vertigo

NCT05676216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2023-07-12

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Vertigo

Interventions

DRUG

Diphenhydramine

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department

DRUG

Sodium Bicarbonate

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department

DRUG

Diphenhydramine + Sodium Bicarbonate

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chien-Yu Chi, MD · Emergency Department, National Taiwan University, Yunlin Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05676216 on ClinicalTrials.gov