Surgery and Anesthesia on ElderlyCGANCT04042064
To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment
An observational study of Surgery and Anesthesia on Elderly and Comprehensive Geriatric Assessment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery and Anesthesia on Elderly, Comprehensive Geriatric Assessment, Aged
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: The elderly population requiring anesthesia.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Participants receiving general anesthesia for longer than 1 hour.
Who cannot join
- Participants receiving local anesthesia.
- Participants receiving regional anesthesia.
- Participants receiving general anesthesia for less than 1 hour.
- Participants with psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei
Hung-Jr Chiou, M.D.
About this study
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.
- Keywords
- CGA, Anesthesia for the elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inhalation | Patient anesthetised with Inhalation anesthetic agents. | |
| TIVA (total intravenous anesthesia) | Patient anesthetised with total total intravenous anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Before general anesthesia till 48-hours post-anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery and Anesthesia on ElderlyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042064
- Sponsor's protocol ID
- 201900881B0
- Acronym
- CGA
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment
- ClinicalTrials.gov ID
- NCT04042064
- Acronym / sponsor ID
- CGA / 201900881B0
- Keywords
- CGA, Anesthesia for the elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation | – | –Patient anesthetised with Inhalation anesthetic agents. |
| TIVA (total intravenous anesthesia) | – | –Patient anesthetised with total total intravenous anesthesia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The elderly population requiring anesthesia.
Key inclusion criteria (2 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Participants receiving general anesthesia for longer than 1 hour.
Key exclusion criteria (4 listed)
- Participants receiving local anesthesia.
- Participants receiving regional anesthesia.
- Participants receiving general anesthesia for less than 1 hour.
- Participants with psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Anesthesia on Elderly and Comprehensive Geriatric Assessment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Jr Chiou, M.D. (886-3-3281200 ext. 3624, ma5372@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental Status Examination (time frame: Before general anesthesia till 48-hours post-anesthesia.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.