NCT03703973

Brief Summary

To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

September 27, 2018

Last Update Submit

October 10, 2018

Conditions

Keywords

Postoperative Cognitive DysfunctionLeukocyte Telomere Length

Outcome Measures

Primary Outcomes (11)

  • the neuropsychological test to measure cognitive function

    1 day before surgery(baseline)

  • Mini-Mental score examination [MMSE] used for screening of dementia

    1 day before surgery(baseline)

  • the leukocyte telomere length

    on the surgery day

  • the neuropsychological test to measure cognitive function

    within the first 7 days (plus or minus 2 days) after surgery

  • Mini-Mental score examination [MMSE] used for screening of dementia

    within the first 7 days (plus or minus 2 days) after surgery

  • the neuropsychological test to measure cognitive function

    within the first 3 months (plus or minus 1 month) after surgery

  • Mini-Mental score examination [MMSE] used for screening of dementia

    within the first 3 months (plus or minus 1 month) after surgery

  • the neuropsychological test to measure cognitive function

    within the first 1 year (plus or minus 3 months) after surgery

  • Mini-Mental score examination [MMSE] used for screening of dementia

    within the first 1 year (plus or minus 3 months) after surgery

  • the neuropsychological test to measure cognitive function

    within the first 3 years (plus or minus 1 year) after surgery

  • Mini-Mental score examination [MMSE] used for screening of dementia

    within the first 3 years (plus or minus 1 year) after surgery

Study Arms (2)

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.

Diagnostic Test: Neuropsychology test

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.

Diagnostic Test: Neuropsychology test

Interventions

Neuropsychology testDIAGNOSTIC_TEST

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.

control groupstudy group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We included 1000 Male and female patients undergoing non-cardiac surgery and 50 healthy volunteers at the affiliated hospital of Xuzhou Medical University.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor-in-charge of Anesthetist

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 12, 2018

Study Start

August 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 12, 2018

Record last verified: 2018-10

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