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

NCT04042064 | Unknown

• 1 other identifier: 201900881B0
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery and Anesthesia on Elderly; Comprehensive Geriatric Assessment; Aged

Keywords

CGA; Anesthesia for the elderly

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Inhalation

Patient anesthetised with Inhalation anesthetic agents.

TIVA (total intravenous anesthesia)

Patient anesthetised with total total intravenous anesthesia.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The elderly population requiring anesthesia.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Central Study Contacts

Hung-Jr Chiou, M.D.

CONTACT

886-3-3281200; ma5372@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 1, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: June 30, 2021
• Last Updated: December 2, 2019

Record last verified: 2019-07

Locations

TW (1)