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临床试验/NCT02267031
NCT02267031已完成不适用

The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function: a Randomized Clinical Study

Northern State Medical University2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
2
主要终点
Cognitive function

研究概览

简要总结

Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

详细描述

The moderate hyperventilation resulting in hypocapnia as well as hyperoxia are common features of mechanical ventilation during general anesthesia. While mild hyperventilation is routinely advocated in laparoscopic surgical interventions, increased FiO2 is set to reinforce safety of respiratory support. Hypocapnia may cause disturbances of cerebral blood flow due to narrowing of cerebral vessels and a decrease cerebral blood flow. Hypocapnia is particularly injurious to the brain in premature infants. Factors that may predispose the immature brain to such injury include poorly developed vascular supply to vulnerable areas, antioxidant depletion by excitatory amino acids, and the lipopolysaccharide and cytokine effects that potentiate destruction of white matter. Data from neonates clearly suggest that severe hypocapnia after hyperventilation contribute to adverse neurologic outcomes. The use of high concentrations of oxygen can lead to a number of events such as the formation of harmful free radicals and activation of lipid peroxidation, resulting in secondary brain injury due to hyperoxia, particularly after suffering anoxia of the brain in resuscitated victims of sudden cardiac arrest. It is recommended to use the fraction of oxygen to maintain saturation at the level of 94-98% when performing cardiopulmonary resuscitation (CPR), due to the risk of reperfusion injury. These disturbances of gas exchange, yet transient can interfere in cerebral blood flow and therefore mental functions.

The primary aim of this study was the assessment of the impact of intraoperative gas exchange (hypocapnia, hyperoxia and their combinations) on the state of higher nervous activity

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Age > 18 years and below 80 yrs
  • Elective abdominal endoscopic intervention

排除标准

  • Known cerebral disorder, incl. traumatic injury and severe vascular impairment
  • Known psychiatric illness
  • Severe drug or alcohol abuse
  • Resent stroke (during last 6 months)
  • Pregnancy
  • Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.

结局指标

主要结局

Cognitive function

时间窗: 36 hrs

Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)

次要结局

  • Psychological Changes(6 months)
  • Pain perception(36 hrs)

研究者

发起方
Northern State Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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