POCD: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.

Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.

To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators included 215 Male and female patients undergoing non-cardiac surgery and 30 healthy volunteers at the affiliated hospital of Xuzhou Medical University.

Description

Inclusion Criteria:

• Non-cardiac surgery patients;
• Age is greater than or equal to 60 years old;
• Han Nationality, mother tongue is chinese;
• The 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;
• The Geriatric Depression Scale (GDS) grade 1 or 2;
• The 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.;
• Had severe head and face disease, trauma history or history of surgery;
• The serious body disease and tobacco, wine and other substance abuse history;
• The presence of malignant tumor with shorter survival disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
study group; 215 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. The investigators do the Mini-Mental score examination (MMSE) and neuropsychological tests 1 day before (baseline) and 1 week after surgery without safety issue. Patients will be divided into POCD and non-POCD groups according to the two times tests.
non-surgical group; The investigators enroll 30 healthy volunteers and do the Mini-Mental score examination (MMSE) and neuropsychological tests at 1 day (baseline) and1 week without safety issue. The exclusive purpose of the non-surgical group is to aid in the POCD calculation according to the ISPOCD 1 study definition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the neuropsychological tests	the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement Test,the Finger Tapping Test, the Word Fluency Test and the Building Block Test.	1 day before surgery(baseline)
Mini-Mental score examination [MMSE]	Mini-Mental score examination [MMSE] used for screening of dementia	1 day before surgery(baseline)
the neuropsychological tests	the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement,the Test Finger Tapping Test, the Word Fluency Test and the Building Block Test.	within the first 7 days (plus or minus 2 days) after surgery
Mini-Mental score examination [MMSE]	Mini-Mental score examination [MMSE] used for screening of dementia	within the first 7 days (plus or minus 2 days) after surgery

Collaborators and Investigators

• Sponsor: Xuzhou Medical University

Publications and helpful links

General Publications

• Zhang ZF, Sun QC, Xu YF, Ding K, Dong MM, Han L, Abdul-Mannan, Han Y, Cao JL. Association between preoperative serum homocysteine and delayed neurocognitive recovery after non-cardiac surgery in elderly patients: a prospective observational study. Perioper Med (Lond). 2021 Nov 8;10(1):37. doi: 10.1186/s13741-021-00208-1.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: non-cardiac surgery; Postoperative Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: XYFY2017-KL004-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: within six months after the trial complete

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No