NCT01715597已完成3 期
Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood loss
研究概览
简要总结
The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •uterine myoma
- •be planning to laparoscopic myomectomy
- •images ; the number of myoma <4
- •images ; the diameter of the largest myoma <9cm
排除标准
- •be planning other surgery in addition to laparoscopy
- •clinically significant coagulation abnormality
研究组 & 干预措施
ascorbic acid
Experimental
ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
干预措施: ascorbic acid (Drug)
ascorbic acid
Experimental
ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation
干预措施: Normal saline (Drug)
Control
Placebo Comparator
Normal saline 500ml IV infusion for 2hour
干预措施: Normal saline (Drug)
结局指标
主要结局
blood loss
时间窗: during laparoscopic myomectomy
次要结局
未报告次要终点
研究者
Kidong Kim
Assistant professor in department of OBGY
Seoul National University Hospital
研究点 (1)
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