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临床试验/NCT04042064
NCT04042064Unknown不适用

To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Geriatric Depression Scale - 15

研究概览

简要总结

Aging is a universal and progressive physiological phenomenon clinically characterized by degenerative changes in both the structure and the functional capacity of organs and tissues. A comprehensive geriatric assessment (CGA) has now become a standard assessment for caring for the elderly. CGA is a multidisciplinary team with the goal of improving the overall well-being of the elderly. It encompasses screening, diagnosis and treatment of the elderly. In this study, we use the comprehensive geriatric assessment to study the effects of surgery and anesthesia on elderly patients.

研究设计

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

入排标准

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

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • Participants receiving general anesthesia for longer than 1 hour.

排除标准

  • Participants receiving local anesthesia.
  • Participants receiving regional anesthesia.
  • Participants receiving general anesthesia for less than 1 hour.
  • Participants with psychiatric disorder.

结局指标

主要结局

Geriatric Depression Scale - 15

时间窗: Before general anesthesia till 48-hours post-anesthesia.

The Geriatric Depression Scale (short form) is a screening tool for depression. It is a questionnaire composed of 15 questions. The investigator asks the patient 15 questions in which the patient answers "yes" or "no". Each question weighs 1 point with a minimum score of zero and maximum score of 15. The higher the score, the more likely depression is present. A score of 0 to 5 is normal. A score greater than 5 suggests depression.

Confusion Assessment Method

时间窗: Before general anesthesia till 48-hours post-anesthesia.

The Confusion Assessment Method is a screening tool for delirium. It comprises of four parts: "(1) acute onset and fluctuating course", "(2) inattention", "(3) disorganized thinking", and "(4) altered level of consciousness". "(1) Acute onset and fluctuating course" has two questions and the rest with one question each. The investigator conducts the assessment with the patient answering "yes" or "no" to each question. Delirium is diagnosed under these scenarios: yes to all four questions, yes to (1)+(2)+(3), yes to (1)+(2)+(4).

Mini-Mental Status Examination

时间窗: Before general anesthesia till 48-hours post-anesthesia.

The Mini-Mental Status Examination is a screening tool for dementia. The investigator asks the patient a series of questions to which the patient answers to his or her best ability. Minium score of zero and a maximum score of 30. Lower value represents a worse outcome. A score of less than 24 is considered abnormal.

Barthel Index

时间窗: Before general anesthesia till 48-hours post-anesthesia.

Barthel Index is an ordinal scale used to measure performance in ADL (activities of daily living). It comprises of ten variables describing ADL. A minium of zero and a maximum and 100 is scored. Higher score reflects greater ability to function independently. 60 or less is classified as dependent. Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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