Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of Alpha angle of EXTEM
研究概览
简要总结
Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients undergoing a laparoscopic colorectal cancer surgery
排除标准
- •Renal disease
- •Hepatic disease
- •Neuromuscular disease
- •Coagulation disorder
- •Cardiopulmonary disease
研究组 & 干预措施
Magnesium
Magnesium sulfate infusion during a operation period.
Infusion regimen:
- Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes
- Infusion 15 mg/kg/h of magnesium sulfate throughout the operation
干预措施: Magnesium Sulfate (Drug)
Control
administration of normal saline as a same volume of magnesium sulphate as a same method.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change of Alpha angle of EXTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of maximum clot firmness (MCF) of FIBTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Clot firmness time (CFT) of INTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Alpha angle of INTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Clotting time (CT) of INTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of MCF of INTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of CFT of EXTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of MCF of EXTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of CT of EXTEM
时间窗: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
次要结局
- Change of Hemoglobin(1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day)
- Change of Platelet count(1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day)
- Change of International normalized ratio of prothrombin time(1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day)
- Change of Activated partial thrombin time(1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day)
- Change of Fibrinogen(1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day)
研究者
Hyo-Seok Na
Dr.
Seoul National University Bundang Hospital