Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- brain relaxation score
研究概览
简要总结
Although mannitol is used for brain relaxation during neurosurgery and in the treatment of raised intracranial pressure; there is not a consensus on its safe, effective dose and the duration of its administration. This study aimed to compare the effects of the mannitol in different use times, on the brain relaxation, electrolyte, lactate levels of the blood, peroperative fluid balance and the volume of the urine in supratentorial mass resection surgeries.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intracranial shift >3mm
- •Scheduled for supratentorial mass resection under elective conditions
排除标准
- •Decompensated heart failure
- •kidney insufficiency
- •Diabetes insipidus,
- •Electrolyte imbalance and
- •Who are unconscious
研究组 & 干预措施
Mannitol A
in this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia
干预措施: Mannitol (Drug)
Mannitol B
in this group, Mannitol (1.0g/kg) is given at the time of skin incision
干预措施: Mannitol (Drug)
结局指标
主要结局
brain relaxation score
时间窗: just before dural opening
difference in brain relaxation after drug administration The assessment was performed using a 4-point scale, 1 denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; 2, firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; 3, adequate; 4, perfectly relaxed. In all patients, the degree of brain relaxation was assessed at the time of dural opening and satisfactory brain relaxation was defined as a brain relaxation score of 3 or 4. All the Secondary Outcome Measures below are observed the safety for intraoperative brain debulking during elective supratentorial craniotomy
次要结局
- Blood sodium levels(change in 30 minute intervals in the first 2 hour after study drug administration)
- Blood lactate levels(change in 30 minute intervals in the first 2 hour after study drug administration)
- Fluid balance during operation(change in 30 minute intervals in the first 2 hour after study drug administration)
- Blood potassium levels(change in 30 minute intervals in the first 2 hour after study drug administration)
- Blood chlorine levels(change in 30 minute intervals in the first 2 hour after study drug administration)
研究者
le tian wang
Principal Investigator
Huashan Hospital