Sodium Bicarbonate for Acute Peripheral Vertigo

NCT ID: NCT05676216

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-07
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Diphenhydramine

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

Group Type: ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Sodium Bicarbonate

Intervention Type: DRUG

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

Diphenhydramine with Sodium Bicarbonate

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

Group Type: EXPERIMENTAL

Diphenhydramine + Sodium Bicarbonate

Intervention Type: 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

Interventions

Diphenhydramine

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

Intervention Type: DRUG

Sodium Bicarbonate

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Yu Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Emergency Department, National Taiwan University, Yunlin Branch

Locations

National Taiwan University Yunlin Branch

Yunlin County, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chien-Yu Chi, MD

Role: CONTACT

Y06108@ms1.ylh.gov.tw

+886 0972655833

Facility Contacts

Chien-Yu Chi, MD

Role: primary

Y06108@ms1.ylh.gov.tw

+886 0972655833

References

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.

Reference Type: BACKGROUND

PMID: 35849408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30845218 (View on PubMed)

Other Identifiers

202209092MIND

Identifier Type: -

Identifier Source: org_study_id