NCT04628676已完成不适用
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月1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
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •• Age > 18 years
- •American Society of Anesthesiologist Physical Status Classification System : 1-2
- •Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear
- •Being willing to participate the study
排除标准
- •• Age < 18 years
- •American Society of Anesthesiologist Physical Status Classification System ≥3
- •Concomitant cardiac diseases
- •Concomitant bleeding disorder or coagulopathy
- •Diabetes mellitus
- •Being pregnant
- •Use of contraceptive pills
- •A history of previous shoulder surgery
- •Uncontrolled hypertension during the operation (>180/110 mm Hg)
- •Unrepairable rotator cuff tears
- •Being unwilling to participate the study
研究组 & 干预措施
TXA group
Experimental
tranexamic acid added to irrigation solution
干预措施: tranexamic acid (Drug)
EPN group
Experimental
epinephrine added to irrigation solution
干预措施: Epinephrine (Drug)
结局指标
主要结局
Visual analog scale
时间窗: through study completion, an average of 2 year
Visual analog scale will be rated by surgeon. While 0 is the worst score with no clear vision, 10 was noted as the best score for visual clarity.
次要结局
- total operating time(through study completion, an average of 2 year)
- average mean arterial pressure(through study completion, an average of 2 year)
研究者
erhan bayram
medical doctor
Haseki Training and Research Hospital
研究点 (1)
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