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Association Study Postoperative Cognitive Dysfunction Associated With Inflammation Polymorphism

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ClinicalTrials.gov Identifier: NCT02843152
Recruitment Status : Unknown
Verified July 2016 by dengji wang, Xuzhou Medical University.
Recruitment status was:  Recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
dengji wang, Xuzhou Medical University

Brief Summary:

This study use Loewenstein cognitive function rating scale to meet the standards of the elderly cognitive function assessment. POCD diagnostic criteria used is the recommended value Z current international law, in order to reduce the effects of exercise, we selected 50 cases of patients with age-matched healthy control group as a spouse, the same scale testing. And Loewenstein Assessment Scale cognitive function after some domestic research proved to have good sensitivity, and easy to test small changes in cognitive ability.

Before the investigation began strict inclusion and exclusion criteria, the use of simple intelligence scale exclude preoperative cognitive decline in the elderly significantly, the use of depression rating scale for anxiety rating scale before surgery to exclude severe depression and severe anxiety in elderly self self patient. Testing by the same person in the same way neurocognitive assessment test twice, 7 days apart.

Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few reports of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and control groups of different polymorphisms, polymorphisms Discussion Han population of postoperative cognitive dysfunction associated with susceptibility to find Chinese Han population of postoperative cognitive disorders genetic susceptibility markers, which provide scientific screening and early diagnosis of postoperative cognitive impairment at high risk in accordance with


Condition or disease
POCD

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 330 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Risk Factor Analysis of Postoperative Cognitive Dysfunction and Its Association With Inflammation Related Gene Polymorphism
Study Start Date : May 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Determine the relevance of inflammation-related genes and SNPs of susceptible POCD [ Time Frame: 1 year ]
    In this study of an international research organization POCD recommended Z-score method to determine postoperative cognitive dysfunction, and is divided into POCD and non POCD group, if the composite Z-score ≥1.96 or have two or more individual test Z-score greater than or equal 1.96 considers the patient POCD group, otherwise non POCD group. They were recorded POCD group and non-POCD group education of patients, medical history, surgery time, anesthesia time, and the amount of narcotic drugs, hypotension, hypertension, postoperative pain, complications, smoking, drinking, blood samples were analyzed patient patients with IL-1β, IL-6, IL-10, VDR, BDNF gene polymorphism


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study subjects were Chinese Han population,Xuzhou Medical College Hospital orthopedic ward in elderly patients
Criteria

Inclusion Criteria:

  • Education for primary ((0 <schooling ≤6)
  • The operation time was 60 ~ 180min
  • ASA classification as Class II

Exclusion Criteria:

  • No history of cerebrovascular disease
  • No history of central nervous system injury caused by the impact of other cognitive functions
  • No alcohol dependence and other substance abuse history
  • No vision can severely affect cognitive tests, hearing and limb movement disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843152


Contacts
Contact: dengji wang +8618761420798 574658525@qq.com
Contact: yaodong zhang +8615205217216

Locations
China, Jiangsu
Affiliated Hospital of Xuzhou Medical College Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: dengji wang    +8618761420798    574658525@qq.com   
Contact: yaodong zhang    +8615205217216      
Sponsors and Collaborators
dengji wang
Investigators
Study Chair: junli cao Jiangsu Key Laboratory of Anesthesiology chinese

Responsible Party: dengji wang, Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT02843152     History of Changes
Other Study ID Numbers: 14038789
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Inflammation
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders