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临床试验/NCT03775343
NCT03775343已完成不适用

Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年10月6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
75
试验地点
1
主要终点
Neuropsychological Test Battery Vienna (NTBV)

研究概览

简要总结

This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years).

详细描述

Primary aim of this study is to evaluate changes in cognitive function in the early postoperative phase after minor surgery in patients of older age (≥65 years).

Background: Postoperative cognitive dysfunction can be a serious complication after surgery and is associated with higher mortality.Several studies have demonstrated that major surgery and patients of older age are risk factors for the incidence of cognitive decline in the postoperative phase. Only a few studies investigated the early postoperative changes in cognitive function (< 24 hours) after minor, day case surgeries in older patients (≥65 years), demonstrating a higher incidence than observed ≥1 week after surgery.

Aim of the project: This study aimed to investigate changes in cognitive function after minor surgery in an elderly patient cohort.

It is the effort to plan perioperative care that can reduce the incidence of postoperative cognitive dysfunction in elderly.

Hypothesis: The present study support the hypothesis that changes in cognitive function after ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia group.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients age 65 and older
  • scheduled to undergo elective ocular surgery
  • American Society of Anesthesiologists class I, II or III
  • MMSE score ≥ 24
  • The people signed informed consent.
  • Expected surgical duration <90 minutes
  • Able to follow study instructions.

排除标准

  • Patients age < 65 years
  • Emergent nature of the ocular surgery
  • American Society of Anesthesiologists class IV
  • MMSE score < 24
  • unsigned informed consent
  • Expected surgical duration >90 minutes
  • Not able to follow study instructions.
  • History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack
  • Drug or substance abuse history

结局指标

主要结局

Neuropsychological Test Battery Vienna (NTBV)

时间窗: before surgery (baseline) and 24 hours after surgery

The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; \> -1,5 SD indicating a larger decline in cognitive function).

次要结局

  • Neuropsychological Test Battery Vienna (NTBV)(before surgery(baseline) and 6 hours after surgery)

研究者

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

Marita Windpassinger M.D.

Principal Investigator

Medical University of Vienna

研究点 (1)

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