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临床试验/NCT02056717
NCT02056717已完成不适用

The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization

Severance Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年4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
入组人数
64
试验地点
1
主要终点
Inflammatory reactions

研究概览

简要总结

The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Uterine artery embolization due to multiple myoma or adenomyosis

排除标准

  • Diabetic mellitus
  • Steroid administration
  • Liver or kidney dysfuntion
  • High baseline CRP or leukocytosis (>11,000/μL )
  • Drug allergy

研究组 & 干预措施

Dexamethasone group

Experimental

干预措施: Dexamethasone (Drug)

Control group

Placebo Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

Inflammatory reactions

时间窗: 24 hours

CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h

次要结局

  • Pain(24 hours)
  • Nausea and vomiting(24 hours)
  • Sucessful rate at 3 month after UAE(3 month)

研究者

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

So Yeon Kim

Assistant professor

Severance Hospital

研究点 (1)

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