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Sodium Bicarbonate for Acute Peripheral Vertigo

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05676216
Enrollment
225
Registered
2023-01-09
Start date
2023-01-07
Completion date
2024-12-31
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vertigo

Keywords

Sodium Bicarbonate, Diphenhydramine

Brief 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.

Interventions

DRUGDiphenhydramine

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

DRUGSodium Bicarbonate

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

DRUGDiphenhydramine + 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

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction in vertigo intensityBaseline and 60 minutes after drug administrationReduction in Vertigo Visual Analog Scale (VAS 0\ 10, higher scores mean higher intensity) from baseline

Secondary

MeasureTime frameDescription
Reduction in nausea intensityBaseline and 60 minutes after drug administrationReduction in Nausea Visual Analog Scale (VAS 0\ 10, higher scores mean higher intensity) from baseline
Improvement of ambulatory abilityBaseline and 60 minutes after drug administrationChange in objective ambulatory ability (score 1\ 4, higher scores mean a worse outcome) from baseline
Lethargy60 minutes after drug administrationLethargy score (score 1\ 4, 1 indicates no lethargy and 4 indicates very lethargy)
Emergency Department staying timeup to 24 hoursFrom patients admit to Emergency Department until patients discharge (up to 24 hours)

Countries

Taiwan

Contacts

Primary ContactChien-Yu Chi, MD
Y06108@ms1.ylh.gov.tw+886 0972655833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026