Sodium Bicarbonate for Acute Peripheral Vertigo

NCT05676216 | Unknown

• 1 other identifier: 202209092MIND
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vertigo

Keywords

Sodium Bicarbonate; Diphenhydramine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reduction in nausea intensity

  Baseline and 60 minutes after drug administration

• Improvement of ambulatory ability

  Baseline and 60 minutes after drug administration

• Lethargy

  60 minutes after drug administration

• Emergency Department staying time

  up to 24 hours

Study Arms (3)

Diphenhydramine

ACTIVE COMPARATOR

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

Drug: Diphenhydramine

Sodium Bicarbonate

EXPERIMENTAL

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping

Drug: Sodium Bicarbonate

Diphenhydramine with Sodium Bicarbonate

EXPERIMENTAL

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

Drug: Diphenhydramine + Sodium Bicarbonate

Interventions

Diphenhydramine DRUG

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

Diphenhydramine

Sodium Bicarbonate DRUG

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

Sodium Bicarbonate

Diphenhydramine + Sodium Bicarbonate DRUG

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

Diphenhydramine with Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute onset vertigo

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Yunlin Branch

Yunlin County, Taiwan

RECRUITING

Related Publications (3)

• Hunter BR, Wang AZ, Bucca AW, Musey PI Jr, Strachan CC, Roumpf SK, Propst SL, Croft A, Menard LM, Kirschner JM. Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Sep 1;79(9):846-855. doi: 10.1001/jamaneurol.2022.1858.

  PMID: 35849408 BACKGROUND

• Numata K, Shiga T, Omura K, Umibe A, Hiraoka E, Yamanaka S, Azuma H, Yamada Y, Kobayashi D. Comparison of acute vertigo diagnosis and treatment practices between otolaryngologists and non-otolaryngologists: A multicenter scenario-based survey. PLoS One. 2019 Mar 7;14(3):e0213196. doi: 10.1371/journal.pone.0213196. eCollection 2019.

  PMID: 30845218 BACKGROUND

• Chi CY, Chen YC, Cheng MT, Chang KC, Chen YP, Tsai MS, Chang WT, Ma MH, Huang CH, Chiang WC. Diphenhydramine, Sodium Bicarbonate, or Combination for Acute Peripheral Vertigo: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2541472. doi: 10.1001/jamanetworkopen.2025.41472.

  PMID: 41196596 DERIVED

MeSH Terms

Conditions

Vertigo

Interventions

Diphenhydramine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chien-Yu Chi, MD

  Emergency Department, National Taiwan University, Yunlin Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Yu Chi, MD

CONTACT

+886 0972655833; Y06108@ms1.ylh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 9, 2023
• Study Start: January 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)