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临床试验/NCT05676216
NCT05676216招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年1月7日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

干预措施: Diphenhydramine (Drug)

Sodium Bicarbonate

Experimental

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping

干预措施: Sodium Bicarbonate (Drug)

Diphenhydramine with Sodium Bicarbonate

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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