Clinical trial NCT03084393: POCD: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
Official title: Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Keywords: non-cardiac surgery
Postoperative Cognitive Dysfunction
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 215
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: the neuropsychological tests
timeFrame: 1 day before surgery(baseline)
measure: Mini-Mental score examination [MMSE]
timeFrame: 1 day before surgery(baseline)
measure: the neuropsychological tests
timeFrame: within the first 7 days (plus or minus 2 days) after surgery
measure: Mini-Mental score examination [MMSE]
timeFrame: within the first 7 days (plus or minus 2 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
citation: 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.