Sodium Bicarbonate for Acute Peripheral Vertigo

Peripheral Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676216
• Other study ID #: 202209092MIND
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: Chien-Yu Chi, MD
• Phone: +886 0972655833
• Email: Y06108[@]ms1.ylh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Peripheral Vertigo
• Vertigo

Intervention

Drug:
• Diphenhydramine
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
• Sodium Bicarbonate
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Yunlin Branch	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Lethargy	Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy)	60 minutes after drug administration
Secondary	Emergency Department staying time	From patients admit to Emergency Department until patients discharge (up to 24 hours)	up to 24 hours