NCT02843152

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

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
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

June 25, 2016

Last Update Submit

July 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine the relevance of inflammation-related genes and SNPs of susceptible POCD

    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

    1 year

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study subjects were Chinese Han population,Xuzhou Medical College Hospital orthopedic ward in elderly patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, 221000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

  • junli cao

    Jiangsu Key Laboratory of Anesthesiology chinese

    STUDY CHAIR

Central Study Contacts

yaodong zhang

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 25, 2016

First Posted

July 25, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations