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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04042064
Other study ID # 201900881B0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date June 30, 2021

Study information

Verified date July 2019
Source Chang Gung Memorial Hospital
Contact Hung-Jr Chiou, M.D.
Phone 886-3-3281200
Email ma5372@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date June 30, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Aged
  • Comprehensive Geriatric Assessment
  • Surgery and Anesthesia on Elderly

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mini-Mental Status Examination 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.
Before general anesthesia till 48-hours post-anesthesia.
Primary Geriatric Depression Scale - 15 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.
Before general anesthesia till 48-hours post-anesthesia.
Primary Confusion Assessment Method 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).
Before general anesthesia till 48-hours post-anesthesia.
Primary Barthel Index 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
Before general anesthesia till 48-hours post-anesthesia.
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