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临床试验/NCT07554170
NCT07554170已完成4 期

Comparison of Single-syringe vs. Double-syringe Techniques for Adenosine Administration in Supraventricular Tachycardia: A Randomized Clinical Trial

Hormozgan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2024年5月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
131
试验地点
1
主要终点
First-dose successful termination of PSVT

研究概览

简要总结

The purpose of the study is to compare the effectiveness of two different methods of administering adenosine for the treatment of stable supraventricular tachycardia (SVT).

详细描述

The American Heart Association 2015 guidelines recommend adenosine for non-hypotensive patients with regular narrow complex SVT. Adenosine is usually given as a rapid intravenous bolus of 6mg over 1-2 seconds, followed by a 20ml saline flush. If the first dose does not result in the termination of SVT to normal sinus rhythm (NSR) within 1-2 minutes, a repeat dose of 12mg can be given, and the dose may be repeated one more time, if necessary, for a total of three doses.

The double-syringe technique (DST) is the standard method for administering adenosine. However, recent studies suggest that the single-syringe technique (SST) may be simpler and potentially beneficial. This technique injects adenosine and saline simultaneously at the same time instead of two separate injections. The study aims to determine if the SST method is non-inferior to the DST method.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 80 years
  • Presentation to the emergency department with narrow-QRS tachyarrhythmia
  • Heart rate ≥150 beats/min
  • No visible P wave or presence of retrograde P wave on ECG
  • Not responsive to Valsalva maneuvers lasting 15 to 30 seconds
  • Requiring adenosine administration

排除标准

  • Wide-QRS tachycardia or irregular R-R interval on ECG
  • Known allergy or contraindication to adenosine
  • Recent ingestion of dipyridamole, carbamazepine, or theophylline
  • Caffeine ingestion within the previous 2 hours

研究组 & 干预措施

Single-syringe technique (SST)

Experimental

干预措施: Single-syringe Adenosine (Drug)

Double-syringe technique (DST)

Active Comparator

干预措施: Double Syringe Adenosine (Drug)

结局指标

主要结局

First-dose successful termination of PSVT

时间窗: Within 2 minutes after administration of the first dose of adenosine.

Proportion of participants with conversion from paroxysmal supraventricular tachycardia to sinus rhythm after the first dose of adenosine.

次要结局

  • Total administered dose of adenosine.(From administration of the first dose until successful termination of PSVT or up to 10 minutes, whichever occurs first.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farima Roshanasan

Emergency Medicine Resident

Hormozgan University of Medical Sciences

研究点 (1)

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