NCT02056717已完成不适用
The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization
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
- 否
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
So Yeon Kim
Assistant professor
Severance Hospital
研究点 (1)
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