Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Reduction in vertigo intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute onset vertigo
排除标准
- •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
研究组 & 干预措施
Diphenhydramine
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping
干预措施: Diphenhydramine (Drug)
Sodium Bicarbonate
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping
干预措施: Sodium Bicarbonate (Drug)
Diphenhydramine with Sodium Bicarbonate
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push
干预措施: Diphenhydramine + Sodium Bicarbonate (Drug)
结局指标
主要结局
Reduction in vertigo intensity
时间窗: Baseline and 60 minutes after drug administration
Reduction in Vertigo Visual Analog Scale (VAS 0\~10, higher scores mean higher intensity) from baseline
次要结局
- Reduction in nausea intensity(Baseline and 60 minutes after drug administration)
- Lethargy(60 minutes after drug administration)
- Improvement of ambulatory ability(Baseline and 60 minutes after drug administration)
- Emergency Department staying time(up to 24 hours)
