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临床试验/NCT03185091
NCT03185091已完成不适用

Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Cerebral oxygenation during surgery

研究概览

简要总结

To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.

详细描述

Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for cerebral aneurysm surgery or arterial venous malformation
  • American Society of Anesthesiologists classification 1, 2, or 3

排除标准

  • 未提供

结局指标

主要结局

Cerebral oxygenation during surgery

时间窗: During surgery

Oxygenation of the brain is measured by near-infrared spectroscopy and by evaluation of the brain tissue oxygen pressure by two microelectrodes placed in the brain.

Cerebral blood flow during surgery

时间窗: During surgery

Thermal diffusion flowmetry measures the local absolute cerebral blood flow

次要结局

  • Electrophysiological changes in the brain during surgery(During surgery)
  • Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing(Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.))
  • Effect of hyperventilation on cerebral parameters after rapid ventricular pacing(Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.))

研究者

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

ethisch.comite@uza.be

Principal Investigator

University Hospital, Antwerp

研究点 (2)

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