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Clinical Trials/NCT04042064
NCT04042064
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country2,000 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery and Anesthesia on Elderly
Sponsor
Chang Gung Memorial Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Geriatric Depression Scale - 15
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
June 30, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Geriatric Depression Scale - 15

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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