Clinical trial NCT02965235: Correlations of Epigenetic Changes With POCD in Surgical Patients
Official title: Correlations of Epigenetic Changes With POCD in Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: central south university,xiangya 2nd hospital,general surgery department

Brief summary: Postoperative cognitive dysfunction (POCD) is a subtle cognitive dysfunction, especially postoperative memory impairment lasting for weeks or months. The underlying pathophysiological mechanism of POCD remain unclear. The aim of this study is to explore the epigenetic changes during perioperative period and its correlation with POCD in surgical patients.

Detailed description: The incidence of postoperative cognitive dysfunction (POCD) in elderly patients ranges widely from 16% to 21% and is associated with adverse outcomes. The exact cause of POCD remains unknown. Extensive studies report that epigenetic modification, including the alteration of DNA methylation and chromatin structure, plays an important part in the regulation of memory and learning. The present study thus hypothesize that epigenetic modification may increase the risk for POCD. The present study will enrolled the elderly patients (aged≥65) and young and middle-aged patents (aged 20-50) who are planning to undergo elective noncardiac surgery under general anesthesia. Perioperative clinical characteristics of all patients will be recorded. Participants enrolled will be evaluated for POCD with Mini-Mental State Examination (MMSE) on preoperative day, postoperative days 1. Postoperative pain will be evaluated by the numerical rating scale (NRS). The patients' blood will be collected in the morning on the day before surgery and after surgery when they recover consciousness for the detection of concentration of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) by enzyme-linked immunosorbent assays (ELISA).

The present study may help to find whether epigenetic changes will occur after surgical and anesthesia stress and will be an important factor for POCD in elderly patients.

Eligibility criteria: Inclusion Criteria:

•ASA Grade I to III Age \>65 BMI 18-28kg/m2 Patients undergoing abdominal surgery,orthopedic surgery and spinal surgery

Exclusion Criteria:

* Exclusion Criteria:

  * do not consent, Patients with mini mental state examination (MMSE)score of ≤20 at screening severe heart,kidney or lung disfunction;unstable angina undergoing abdominal operation previously refuse to use PCA unexpected surgical complication such as bleeding; psychiatric disorders; drug or alcohol abuse

Primary outcomes:
measure: Correlation of epigenetic changes with POCD
timeFrame: 24 hours
Secondary outcomes:
measure: The effects of surgical and anesthesia stress on epigenetic changes
timeFrame: 24 hours
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Anesthesiology, The Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: the second xiangya hospital,central south university
name: Ruping Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li H, Wu TT, Tang L, Liu Q, Mao XZ, Xu JM, Dai RP. Association of global DNA hypomethylation with post-operative cognitive dysfunction in elderly patients undergoing hip surgery. Acta Anaesthesiol Scand. 2020 Mar;64(3):354-360. doi: 10.1111/aas.13502. Epub 2019 Nov 23.