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

NCT ID: NCT03084393

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Han Yuan

Doctor-in-charge of Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34743734 (View on PubMed)

Other Identifiers

XYFY2017-KL004-01

Identifier Type: -

Identifier Source: org_study_id