The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
Meningioma is the most common central nervous system tumor and craniotomy with tumor removal was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can reduce intraoperative blood loss and improve postoperative cognitive function is still inconclusive. So the investigators conduct the randomized control trial to compare the effect of magnesium with placebo control in blood loss and cognitive function in meningioma patient undergoing craniotomy.
详细描述
The investigators enroll 120 patient who admitted for craniotomy for meningioma removal. Then, the patients will be divided into two groups. The first group or group Mg will receive magnesium sulphate 40 mg/kg infuse for 30 min (started at skin incision), and then infuse magnesium sulphate 10 mg/kg/hr until the dura will be closed. The another group or normal saline group will receive the same amount of 0.9% sodium chloride. The anesthesia and surgery are standardized. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative Montreal cognitive assessment score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study drug will prepared by the investigator in the same character and amount. So the patient and care provider will not know the study drug is magnesium or 0.9% sodium chloride.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meningioma patient
- •Schedule for supratentorial craniotomy with tumor removal
- •American society of anesthesiologists physical status 1-3
- •Age 18-70 years
- •No alteration of conscious (full Glasgow coma score) and well cooperate
- •Expected to extubation after operation
排除标准
- •Unstable hemodynamic (severe hypotension or hypertension who receive antihypertensive and vasopressor before surgery but not include baseline oral antihypertensive drug)
- •Known cardiac disease from either history, physical examination or investigation
- •Patient who have heart block
- •Hepatic disease (Child Pugh Score Class C)
- •Renal insufficiency (eGFR < 60 ml/min from Chronic Kidney Disease Epidemiology Collaboration equation)
- •Allergy to magnesium or other drugs use in the study
- •Patient who receive calcium channel blocker drug
- •Pregnancy
- •Patient who receive magnesium for treatment such as arrhythmia or preeclampsia
- •Hypermagnesemia (more than 2.6 mg/dL) before surgery
- •BMI more than 30 kg/m2
- •Patient who probably have brain herniation from increase intracranial pressure
研究组 & 干预措施
Magnesium group
The patient will receive magnesium sulfate injection 40 mg/kg infuse over 30 min started at skin incision and continuous drip 10 mg/kg/hr until the dura is closed
干预措施: Magnesium group (Drug)
Normal saline group
The patient will receive 0.9% sodium chloride the same amount of magnesium sulphate infuse over 30 min started at skin incision and continuous drip until the dura is closed
干预措施: Normal saline group (Drug)
结局指标
主要结局
Intraoperative Blood Loss
时间窗: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
We measure the amount of blood loss in the operative room in suction box, gauze and plastic bag. The unit measure is millimeter.
次要结局
- Fentanyl Requirement(Intraoperative period from skin was incised to the skin was closure, an average 5 hours.)
- Cis-atracurium Requirement(Intraoperative period from skin was incised to the skin was closure, an average 5 hours.)
- Intraoperative Packed Red Cell (PRC) Transfusion(Intraoperative period from skin was incised to the skin was closure, an average 5 hours.)
- Sevoflurane Requirement(Intraoperative period from skin was incised to the skin was closure, an average 5 hours.)
- Postoperative MOCA Score(Postoperative day 3-7)
- Patient Received Intraoperative Packed Red Cell (PRC)(Intraoperative period from skin was incised to the skin was closure, an average 5 hours.)