Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- brain parenchymal relaxation
研究概览
简要总结
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.
详细描述
Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.
In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia
排除标准
- •Patient who does not agree to the study
- •Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
- •Patients with glasgow coma scale (GCS) under 13 points
- •Patients who have hyponatremia or hypernatremia (Na<130 or >150mEq/L)
- •Patients who have congestive heart failure or moderately decreased renal function (GFR <60ml/min/1.73m2)
- •Patients with extraventricular drainage such as external ventricular drain (EVD) or ventriculoperitoneal (VP) shunt
- •Patients who already under mannitolization
研究组 & 干预措施
Group 1
0.25g/kgof 20% mannitol administered at drilling of skull.
干预措施: 0.25g/kgof 20% mannitol (Drug)
Group 2
0.5g/kg of 20% mannitol administered at drilling of skull.
干预措施: 0.5g/kg of 20% mannitol (Drug)
Group 3
1.0 g/kg of 20% mannitol administered at drilling of skull.
干预措施: 1.0g/kg of 20% mannitol (Drug)
Group 4
1.5g/kg of 20% mannitol administered at drilling of skull.
干预措施: 1.5g/kg of 20% mannitol (Drug)
结局指标
主要结局
brain parenchymal relaxation
时间窗: intraoperative
Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol. 3 and 4 scale means brain relaxed. We would analyse if the success proportion of brain relaxation increase according to the mannitol increment 0.25g/kg, 0.5g/kg, 1.0g/kg and 1.5g/kg using Cochran-Armitage trend test.
次要结局
- Electrolyte change(at baseline, 30 min, 60min and 180 min after the administration of the study drug)
- Brain relaxation score(intraoperative)
- Hemodynamic change(at baseline, 30 min, 60min and 180 min after the administration of the study drug)
- Urine output(at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading)
- Osmolar gap change(at baseline, 30min, 60min and 180 min after the administration of the study drug)
研究者
Hee-Pyoung Park
Professor
Seoul National University Hospital