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临床试验/NCT02285634
NCT02285634已完成不适用

The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
68
试验地点
1
主要终点
Change in Mean Arterial Blood Pressure

研究概览

简要总结

Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly inciting 1 in 200 visits. They are most common in those less than ten and older than seventy, often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated with elevated blood pressures, but it is controversial whether hypertension is actual a contributing cause.

In non-life-threatening epistaxis, the first step in management is commonly the application of a topical vasoconstrictive medication. In many cases this will lead to cessation of the bleeding or facilitate the exam in those that continue to bleed. Frequently used medications include phenylephrine, oxymetazoline, and lidocaine with epinephrine.

Classic teaching has been to avoid the use of these medications in patients with elevated blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical vasoconstrictors in this patient group with epistaxis severely limits the treatment options for a many patients given the association between the two conditions.

Though universally taught, the actual effect of these agents on blood pressure remains unquantified. Studies investigating the prevention of nose bleeding during nasotracheal intubations suggest that the effect might be minor with little variation between agents.

Clinical question:

What is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.

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
Double (Participant, Investigator)

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

  • Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus.
  • We will recruit a convenience sample of 100 patients from the Emergency Department who have completed their Emergency Department evaluation and treatment and are being discharged to home with non-painful conditions.

排除标准

  • We will exclude persons under the age of eighteen
  • Vulnerable populations (pregnant patients and prisoners)
  • Those with an allergy to any of the study agents
  • Those with acute pain
  • Those using antihypertensive or antiarrhythmic agents
  • Those with significant cardiopulmonary comorbidities (namely history of arrhythmia, coronary artery disease, hypertension, and heart failure)
  • Those with concomitant use of Monoamine oxidase A (MAO) Inhibitors
  • Those with a diagnosis of angle closure glaucoma or benign prostatic hyperplasia (BPH)
  • Those with a history of cerebrovascular disease
  • As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.

研究组 & 干预措施

Oxymetazoline 0.05%

Experimental

Oxymetazoline 0.05%

干预措施: Oxymetazoline 0.05% (Drug)

Phenylephrine 0.25%

Experimental

Phenylephrine 0.25%

干预措施: Phenylephrine 0.25% (Drug)

Bacteriostatic 0.9% sodium chloride (NaCL)

Placebo Comparator

Bacteriostatic 0.9% NaCL

干预措施: Bacteriostatic 0.9% NaCL (Drug)

结局指标

主要结局

Change in Mean Arterial Blood Pressure

时间窗: baseline, 30 minutes

Change in mean arterial blood pressure from the baseline measurement

次要结局

  • Change in Systolic Blood Pressure(baseline, 30 minutes)
  • Change in Diastolic Blood Pressure(baseline, 30 minutes)
  • Change in Heart Rate(baseline, 30 minutes)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tobias Kummer

Assistant Professor of Emergency Medicine

Mayo Clinic

研究点 (1)

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