Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- serum chloride difference (mmol/L)
研究概览
简要总结
Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children undergoing elective craniotomy for brain tumor resection
- •Informed consent form signed and dated by legal guardian and investigator
- •Informed assent form signed by the patient if appropriate
排除标准
- •Uncontrolled Intracranial hypertension
- •Severe heart, kidney, or pulmonary disease
- •non-corrected electrolyte imbalance
- •allergy to the solution administered
研究组 & 干预措施
Normal Saline Group
the patients included in this group will receive normal saline solution (0.9% sodium chloride) during surgery and in the first 24 hours after ICU admission.
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
serum chloride difference (mmol/L)
时间窗: from the admission of the patient in the operating room until the end of the surgery.
Serum chloride will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
次要结局
- serum chloride difference (mmol/L)(from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU))
- brain relaxation score(immediately after dura-mater opening)
- serum sodium difference (mmol/L)(from the admission of the patient in the operating room until the end of the surgery.)
研究者
Mariana Fontes Lima Neville
Principal Investigator
Federal University of São Paulo