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临床试验/NCT03963063
NCT03963063已完成不适用

Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年6月27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
70
试验地点
2
主要终点
duration of cerebral desaturation events

研究概览

简要总结

Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Investigators design this study to test the efficacy of perioperative goal-directed therapy in preventing cerebral desaturation and postoperative cognitive dysfunction in patients receiving beach chair position shoulder surgery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients receiving scheduled beach chair position shoulder surgery

排除标准

  • pregnant women
  • patients in intensive care units
  • patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%]
  • patients with heart failure(NYHA score =III、IV)
  • patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2)
  • patients with liver failure
  • patients with ongoing infection
  • patients allergic to voluven

结局指标

主要结局

duration of cerebral desaturation events

时间窗: 3 hours

patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events

次要结局

  • incidence of cerebral desaturation events(3 hours)
  • postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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