NCT01601314已完成3 期
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Sara Varea1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Serum S100B protein
研究概览
简要总结
The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females older than 18 years.
- •Undergoing supratentorial parenchyma resection surgery.
- •Capable of collaborate on probes and explorations included in the study.
- •Signature the written informed consent form.
排除标准
- •Life expectancy less than 12 months due to the suspected histological type of tumour.
- •Hypothalamic-pituitary axis illness.
- •Presence of Melanoma previously.
- •Glomerular filtration rate less than 60 mL/min.
- •Thyroid or parathyroid glands pathology.
- •Myasthenia gravis.
- •Respiratory depression.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
magnesium sulphate
Experimental
The patients who are going to receive Magnesium Sulphate
干预措施: Magnesium Sulfate (Drug)
Control
Placebo Comparator
Patients who are going to receive Sodium Chloride 0.9%
干预措施: Sodium Chloride (Other)
结局指标
主要结局
Serum S100B protein
时间窗: 2 hours after the end of the surgery
次要结局
- Glasgow Outcome Scale(6 and 12 month postoperative)
- Mortality(6 and 12 month postoperative)
- Improvement on Neuropsychological Assessment(within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative)
- Apolipoprotein E genotype(1 hour before surgery)
- Serum S100B protein(1 hour before surgery; daily postoperative until day 10.)
- Serum Specific Neuronal Enolase (SNE)(1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10)
- Improvement on Magnetic Resonance Imaging(within the month prior to surgery; early postoperative; 6 months postoperative)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (1)
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