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

NCT03084393 | Completed

• 1 other identifier: XYFY2017-KL004-01
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

non-cardiac surgery; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

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.;
• 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.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (1)

• 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.

  PMID: 34743734 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)