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

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.

Study Overview

• Status: Unknown
• Conditions: Aged; Comprehensive Geriatric Assessment; Surgery and Anesthesia on Elderly

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Hung-Jr Chiou, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The elderly population requiring anesthesia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Inhalation; Patient anesthetised with Inhalation anesthetic agents.
TIVA (total intravenous anesthesia); Patient anesthetised with total total intravenous anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: CGA; Anesthesia for the elderly
• Other Study ID Numbers: 201900881B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No