The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
研究概览
简要总结
Increased brain bulk may be problematic during brain surgery for tumors because it may limit surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration and its side effects (e.g., low blood pressure). Our purpose is to investigate what the effects of furosemide are in the setting of brain surgery for tumors, specifically with regards to decreasing brain bulk and/or causing dehydration.
Study Hypothesis: The addition of furosemide to mannitol will result in improved brain relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen with mannitol alone. However, the combination of mannitol and furosemide will also lead to more significant intravascular volume depletion than that seen with mannitol alone.
详细描述
Rating of brain relaxation will be on a 4-point scale:
0 = brain very relaxed under dura, acceptable
- = brain adequately relaxed under dura, acceptable
- = brain slightly tense under dura, acceptable
- = brain very tense under bulging dura, unacceptable
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include:
- •ASA PS I-III
- •Age 18 or older
- •Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)
排除标准
- •• ASA PS IV or V
- •Age less than 18
- •Emergency surgery due to severely elevated ICP/impending brainstem herniation
- •Concurrent use of diuretics for any indication
- •Infratentorial/posterior fossa/cerebellar tumor resection
- •Moderate/severe cardiac disease with limitation in contractility as measured by preoperative echocardiogram (EF < 30%)
- •Severe pulmonary hypertension as measured and/or observed by preoperative studies
- •Preoperative use of steroids (within 6 months, including those on standing doses)
- •Pregnancy
研究组 & 干预措施
Furosemide
Furosemide 0.3 mg/kg
干预措施: Furosemide (Drug)
Placebo
Up to 5 mL saline
干预措施: Placebo (Drug)
结局指标
主要结局
Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
时间窗: just prior to dural opening for each subject
Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable 1. = brain adequately relaxed under dura, acceptable 2. = brain slightly tense under dura, acceptable 3. = brain very tense under bulging dura, unacceptable
次要结局
未报告次要终点
研究者
John Bebawy
Assistant Professor of Anesthesiology & Neurological Surgery
Northwestern University