- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03703973
Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Jiangsu
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Xuzhou, Jiangsu, China
- Recruiting
- Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Non-cardiac surgery patients;
Age is greater than or equal to 65 years old;
Han Nationality, mother tongue is chinese;
④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
⑤The Geriatric Depression Scale (GDS) grade 1 or 2;
⑥The important function without serious heart, brain, liver, kidney, lung and other organs;
The ASA class I or II;
- The people signed informed consent.
Exclusion Criteria:
The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②Had severe head and face disease, trauma history or history of surgery;
- Had a history of influenza in 3 weeks; ④The serious body disease and tobacco, wine and other substance abuse history; ⑤The presence of malignant tumor with shorter survival disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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study group
1000 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China].
We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.We also measure their preoperative leukocyte telomere length.
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We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.
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control group
We enroll 50 healthy volunteers and do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test at 1 day (baseline), 1 week, 3 months, 1 year and 3 years without safety issue.
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We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the neuropsychological test to measure cognitive function
Time Frame: 1 day before surgery(baseline)
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1 day before surgery(baseline)
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Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: 1 day before surgery(baseline)
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1 day before surgery(baseline)
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the leukocyte telomere length
Time Frame: on the surgery day
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on the surgery day
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the neuropsychological test to measure cognitive function
Time Frame: within the first 7 days (plus or minus 2 days) after surgery
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within the first 7 days (plus or minus 2 days) after surgery
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Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: within the first 7 days (plus or minus 2 days) after surgery
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within the first 7 days (plus or minus 2 days) after surgery
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the neuropsychological test to measure cognitive function
Time Frame: within the first 3 months (plus or minus 1 month) after surgery
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within the first 3 months (plus or minus 1 month) after surgery
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Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: within the first 3 months (plus or minus 1 month) after surgery
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within the first 3 months (plus or minus 1 month) after surgery
|
|
the neuropsychological test to measure cognitive function
Time Frame: within the first 1 year (plus or minus 3 months) after surgery
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within the first 1 year (plus or minus 3 months) after surgery
|
|
Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: within the first 1 year (plus or minus 3 months) after surgery
|
within the first 1 year (plus or minus 3 months) after surgery
|
|
the neuropsychological test to measure cognitive function
Time Frame: within the first 3 years (plus or minus 1 year) after surgery
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within the first 3 years (plus or minus 1 year) after surgery
|
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Mini-Mental score examination [MMSE] used for screening of dementia
Time Frame: within the first 3 years (plus or minus 1 year) after surgery
|
within the first 3 years (plus or minus 1 year) after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POCDLTL
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