Correlations of Epigenetic Changes With POCD in Surgical Patients

NCT02965235 | Unknown DMC

• 1 other identifier: XYEYYLH20151209
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Correlation of epigenetic changes with POCD

  The present study will examine concentration of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) in whole blood by enzyme-linked immunosorbent assays (ELISA) to determine the correlation of epigenetic changes with POCD in surgical patients.

  24 hours

Secondary Outcomes (1)

• The effects of surgical and anesthesia stress on epigenetic changes

  24 hours

Study Arms (2)

non-POCD

Patients who don't develop POCD after surgery.

POCD

Patients who develop POCD after surgery.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

central south university,xiangya 2nd hospital,general surgery department

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

Related Publications (1)

• 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.

  PMID: 31715023 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

For analysis of epigenetic changes

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 Officials

• Ruping Dai, MD

  The Second Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)