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Status unknownNCT02965235Updated Nov 16, 2016

Correlations of Epigenetic Changes With POCD in Surgical Patients

An observational study in Postoperative Cognitive Dysfunction, sponsored by Central South University. Status unknown at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-11-16.

Sponsored by Central South University · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Postoperative Cognitive Dysfunction
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In context

Postoperative Cognitive Complications

264 studies on the registry are indexed under Postoperative Cognitive Complications; 54 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 113 observational studies indexed under Postoperative Cognitive Complications.

Browse Postoperative Cognitive Complications studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • non-POCD

    Patients who don't develop POCD after surgery.

  • POCD

    Patients who develop POCD after surgery.

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What researchers measure

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.

    Time frame: 24 hours

Secondary outcomes

  1. The effects of surgical and anesthesia stress on epigenetic changes

    Numerous studies have reported that both acute and chronic stress can cause epigenetic modification. Surgical stress also belongs to acute stress during perioperative period. Thus the present study will compare concentration of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) before and after operation to determine whether surgical and anesthesia stress will induce epigenetic changes.

    Time frame: 24 hours

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Study locations

1 site
  • Department of Anesthesiology, The Second Xiangya Hospital
    Changsha, Hunan 410011, China
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References and documents

Publications

  • 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. PubMed 31715023 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02965235
Lead sponsor
Central South University
Responsible party
Ru-Ping Dai (Professor, MD, PhD, Central South University) — Principal investigator
First posted
Nov 16, 2016
Start date
Sep 2016
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Nov 16, 2016

Study contacts

Ruping Dai, MD
principal investigator · the second xiangya hospital,central south university

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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