Sodium Bicarbonate for Acute Peripheral Vertigo

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Vertigo
• Intervention / Treatment: Drug: Diphenhydramine; Drug: Sodium Bicarbonate; Drug: Diphenhydramine + Sodium Bicarbonate

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chien-Yu Chi, MD; Phone Number: +886 0972655833; Email: Y06108@ms1.ylh.gov.tw

Study Locations

• Taiwan
  • Yunlin County, Taiwan
    • Recruiting
    • National Taiwan University Yunlin Branch
    • Contact: Chien-Yu Chi, MD; Phone Number: +886 0972655833; Email: Y06108@ms1.ylh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chien-Yu Chi, MD, Emergency Department, National Taiwan University, Yunlin Branch

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Diphenhydramine; Sodium Bicarbonate
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine
• Other Study ID Numbers: 202209092MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No