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临床试验/NCT03372135
NCT03372135已完成不适用

Postoperative Cognitive Deficit After Steep Trendelenburg Position and CO2 Pneumoperitoneum With Cerebral Oxygen: A Prospective Observational Pilot Study

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2017年1月1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
147
试验地点
1
主要终点
Diagnosis of postoperative cognitive dysfunction

研究概览

简要总结

Postoperative cognitive decline (POCD) is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. The robot-assisted radical cystectomy (RARC) is increasingly utilized. In patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can increase the cerebral blood flow, the excessive cerebral perfusion can lead to encephalemia, which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. The goal of the current study is to investigate the combined effect of this position and CO2 pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.

详细描述

Postoperative cognitive decline (POCD) is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. It is a common and impactful outcome of surgical procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly understood. It is supposed to be associated with numerous factors such as ages, trauma, inflammation, surgical stress, position, fluid, MBP, artificial pneumoperitoneum , PCO2, FiO2.

The robot-assisted radical cystectomy (RARC) is increasingly utilized. In patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can increase the cerebral blood flow, there were studies showed that the excessive cerebral perfusion can lead to encephalemia, which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. Contemporary, intraoperative fluid restriction, a relatively long time of operation and surgical stress may also contribute to POCD.

The goal of the current study is to investigate the combined effect of this position and CO2 pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Above age of 55
  • Will undergo the robot-assisted radical cystectomy
  • informed consent, volunteered to participate in this experiment, ASA I - III

排除标准

  • Audio and visual impairment, illiteracy
  • Existing severe central nervous system disease
  • Patients with central nervous system disease or surgery , resulted in severe sequelae
  • Alcohol dependence
  • Take psychotropic medications
  • Preoperative MMSE score was less than 24

结局指标

主要结局

Diagnosis of postoperative cognitive dysfunction

时间窗: One week after surgery

Using Z score method to analyse and comprehensively evaluate cognitive dysfunction scale which can help diagnosing the incidence of POCD.

次要结局

  • The effect of steep Trendelenburg position and CO2 Pneumoperitoneum on POCD(1 year)
  • Probable risk factors of POCD(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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