Postoperative Cognitive DysfunctionNCT02965235
Correlations of Epigenetic Changes With POCD in Surgical Patients
An observational study of Postoperative Cognitive Dysfunction, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: central south university,xiangya 2nd hospital,general surgery department
Who may be able to join
- •ASA Grade I to III Age >65 BMI 18-28kg/m2 Patients undergoing abdominal surgery,orthopedic surgery and spinal surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Second Xiangya Hospital
Changsha, Hunan, 410011
About this study
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-POCD | Patients who don't develop POCD after surgery. | |
| POCD | Patients who develop POCD after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Ping Dai, Central South University
- Investigators
- Ruping Dai, MD, Principal investigator, The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965235
- Sponsor's protocol ID
- XYEYYLH20151209
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations of Epigenetic Changes With POCD in Surgical Patients
- ClinicalTrials.gov ID
- NCT02965235
- Acronym / sponsor ID
- XYEYYLH20151209
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-POCD | – | –Patients who don't develop POCD after surgery. |
| POCD | – | –Patients who develop POCD after surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- central south university,xiangya 2nd hospital,general surgery department
Key inclusion criteria (1 listed)
- •ASA Grade I to III Age >65 BMI 18-28kg/m2 Patients undergoing abdominal surgery,orthopedic surgery and spinal surgery
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of epigenetic changes with POCD
Time frame: 24 hours
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.
1 secondary outcome
The effects of surgical and anesthesia stress on epigenetic changes
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 31715023Li 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.
- Individual participant dataSharing planned: No
Related trials for Postoperative Cognitive Dysfunction
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Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
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The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruping Dai, MD principal investigator
The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of epigenetic changes with POCD (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.