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临床试验/NCT02713087
NCT02713087已完成4 期

Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors

University of Aarhus1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Capillary Transit Time Heterogeneity

研究概览

简要总结

Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors

Sponsor-investigator: Klaus Ulrik Koch M.D.

Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark

Objective:

To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with brain tumors. Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine

Method:

Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are infused intravenously under general anesthesia. MRI is performed in 20 patients before and after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS monitoring will be used in either scanner. After scanning patients are transported to the operating theatre and the craniotomy is performed. After removal of the bone flap subdural ICP is measured and recorded.

MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured.

Data from the proposed studies will add substantial new knowledge to the investigators current understanding of the effects of vasopressors on cerebral circulation. This information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the choice of the optimal method to manage cerebral perfusion pressure during craniotomy for brain tumor.

详细描述

Background:

During brain tumor surgery the main objective for the neuroanesthesiologist is to maintain a low intracranial pressure (ICP) and a sufficient cerebral perfusion pressure (CPP) (CPP = mean arterial blood pressure [MABP] - ICP) to ensure adequate cerebral oxygenation. Brain tumors are often associated with edema and increased ICP and a specific recommendation for CPP thresholds during brain tumor surgery does not exist. In daily practice vasopressors are used to increase MABP to maintain a CPP between 50-70 mmHg in accordance with current guidelines for management of patients with traumatic brain pathology.

However, recent studies show that arterial blood pressure correlates only poorly with microcirculatory flow. Elevation of blood pressure may result in reduced capillary perfusion and oxygen delivery despite reaching resuscitation end-points with CPP within 50-70 mmHg. This is supported by an experimental study demonstrating vasopressor-induced mismatch between cerebral perfusion and oxygenation, possibly due to microvascular heterogeneity, as suggested by the authors. In addition, recent studies in healthy anesthetized subjects demonstrate that, despite an increase in MABP, cerebral oxygenation simultaneously decreases after phenylephrine but remains unchanged after administration of ephedrine. Thus, increasing CPP with vasopressors may lead to paradoxical microcirculatory response with vasopressor-induced tissue hypo-perfusion and hindered tissue oxygenation.

Brain microcirculation is the primary site of oxygen exchange. The investigators have recently proposed that red blood cell capillary transit time heterogeneity (CTTH) may affect tissue oxygen tension in patients with ischemic stroke, subarachnoid hemorrhage and traumatic brain injury. According to this theory capillary compression due to edema and elevated ICP may cause redistribution of capillary flows into patterns with functional shunting of oxygenated blood through the cerebral capillary bed. This capillary dysfunction may further hinder oxygen diffusion into cerebral tissue and ultimately cause cerebral ischemic damage. The dissimilar effects of phenylephrine and ephedrine on cerebral oxygenation may be caused by a different influence on brain capillary perfusion or alternated CTTH. Currently there are no studies available on the effects of commonly used vasopressors on brain microcirculation and oxygenation in patients undergoing craniotomy for brain tumors.

Hypothesis:

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images)
  • ASA (American Society of Anesthesiologist) status 1-3 (27)
  • Written informed consent from participating patients

排除标准

  • Age younger than 18 yrs. or older than 75 yrs.
  • Pregnancy or nursing (negative pregnancy blood test)
  • History of allergic reactions to phenylephrine or ephedrine
  • eGFR < 60ml/min/1.73m2

研究组 & 干预措施

Ephedrine

Active Comparator

干预措施: Ephedrine (Drug)

Phenylephrine

Active Comparator

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Capillary Transit Time Heterogeneity

时间窗: 4 Years

次要结局

  • Cerebral Metabolic Rate of Oxygen(4 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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