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临床试验/NCT02537106
NCT02537106已完成不适用

A Comparison of the Effect of 1.5% Versus 3% NaCl on Brain Relaxation and Microcirculation During the Supratentorial Brain Tumor Surgery, and Natremia and Osmolarity in Postoperative Period

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

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
Changes in brain microcirculation

研究概览

简要总结

Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and natriuresis is less pronounced.

详细描述

All the patients meeting the study criteria will be randomized into two groups. After standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic NaCl 5 ml/kg/BW during 30 min, group A 1.5% NaCl, group B 3% NaCl. Corticosteroids will be administered as usually. After dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of SDF probe in the area of the healthy brain, and of perifocal oedema. Both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. Laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after NaCl infusion and at the end of surgery. Concentration of natrium will be examined in CSF after dura opening. Anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.

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

  • •peripheral supratentorial brain tumors or metastasis
  • •indication for osmotherapy
  • •ASA status I-III

排除标准

  • •reoperation
  • •osmotherapy prior to surgery
  • •preoperative natremia less than 135 mmol/l and more than 140 mmol/l
  • •GCS less than 14
  • •obstructive hydrocephalus

研究组 & 干预措施

1.5% NaCl

Experimental

After standardized induction to general anesthesia group A patients will be given the infusion of hyperosmotic 1.5% NaCl 5 ml/kg/BW during 15 min.

干预措施: 1.5% NaCl (Procedure)

3% NaCl

Experimental

After standardized induction to general anesthesia group B patients will be given the infusion of hyperosmotic 3% NaCl 5 ml/kg/BW during 15 min.

干预措施: 3% NaCl (Procedure)

结局指标

主要结局

Changes in brain microcirculation

时间窗: from dura opening till the end of tumor resection

measurement by SDF probe MicroVision

次要结局

  • Changes in natremia(5 min after the end of surgery)
  • Changes in osmolarity(5 min after the end of surgery)
  • Concentration of natrium in cerebrospinal fluid(after dura opening)
  • Changes in natremia(1 hour after hypertonic NaCl infusion)
  • Changes in osmolarity(1 hour after hypertonic NaCl infusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dostalova Vlasta, MD, PhD

Dostalova Vlasta, MD, PhD

University Hospital Hradec Kralove

研究点 (1)

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