Sodium Bicarbonate for Acute Peripheral Vertigo
- Conditions
- Peripheral Vertigo
- Interventions
- Registration Number
- NCT05676216
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 225
- Patients with acute onset vertigo
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diphenhydramine with Sodium Bicarbonate Diphenhydramine + Sodium Bicarbonate Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push Diphenhydramine Diphenhydramine Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping Sodium Bicarbonate Sodium Bicarbonate Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping
- Primary Outcome Measures
Name Time Method Reduction in vertigo intensity Baseline and 60 minutes after drug administration Reduction in Vertigo Visual Analog Scale (VAS 0\~10, higher scores mean higher intensity) from baseline
- Secondary Outcome Measures
Name Time Method Reduction in nausea intensity Baseline and 60 minutes after drug administration Reduction in Nausea Visual Analog Scale (VAS 0\~10, higher scores mean higher intensity) from baseline
Lethargy 60 minutes after drug administration Lethargy score (score 1\~4, 1 indicates no lethargy and 4 indicates very lethargy)
Improvement of ambulatory ability Baseline and 60 minutes after drug administration Change in objective ambulatory ability (score 1\~4, higher scores mean a worse outcome) from baseline
Emergency Department staying time up to 24 hours From patients admit to Emergency Department until patients discharge (up to 24 hours)
Trial Locations
- Locations (1)
National Taiwan University Yunlin Branch
🇨🇳Yunlin County, Taiwan