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AgingPOEMNCT04219033

Postoperative Cognitive Function and EEG

An observational study of Aging and Postoperative Cognitive Dysfunction, run by Air Force Military Medical University, China at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the elderly patients undergoing elective non-cardiac major surgery, the differences of EEG parameters between those with and without postoperative cognitive dysfunction were observed to determine the characteristic changes of EEG parameters related to postoperative cognitive dysfunction Read more about this study

Who is it for?
Ages 65 to 100 years
What is being tested?
EEG(Electroencephalogram) change
How many people
1,250 participants
Where
18 sitesChina
Study dates
5 May 2020to 30 Apr 2023
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 1150 cases in the elderly group and 100 cases in the adult background group

Who may be able to join

  • aged 65 and above
  • non-cardiac surgery under general anesthesia;
  • American Society of Anesthesiology(ASA) classification I- II
  • Patients aged 18-40 years old are set as background

Who cannot join

  • patients with central nervous system diseases and mental diseases
  • preoperative minimal mental status examination(MMSE) score<24;
  • ASA status III or higher
  • 3) those who have received less than 5 years of education since entering primary school; 4) history of sedatives or antidepressants use; 5) existed or anticipated alcohol or drug abuse(over 40°c and over 100ml per day for the past 3 months); 6) history of surgery within the previous year; 7) those with severe visual or hearing impairment; 8) those participated in other clinical studies within last 3 months;

Trial locations and contacts

18 sites in 1 country.

Hailong Dong contact

862984775337

hldong6@hotmail.com

Zhihong Lu contact

8613891975018 ext. 8613891975018

deerlu23@163.com

18 sites in 1 country

China18 sites, 18 recruiting

  • China-Japan Friendship Hospital

    Beijing

    Jing Zhao

    Recruiting

  • Xinqiao Hospital of Army Medical University

    Chongqing

    Hong Li

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Min Yan, 0571-87767223, zryanmin@zju.edu.cn

    Recruiting

  • The First Affiliated Hospital Nanchang University

    Nanchang, Jiangxi

    Shibiao Chen

    Recruiting

  • People's Hospital of Jiangsu

    Nanjing

    Cunming Liu

    Recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

    Yugang Diao

    Recruiting

  • Suzhou First People's Hospital

    Suzhou, Jiangsu

    Fuhai Ji

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Shouyuan Tian

    Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Linzhong Zhang

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Chongfang Han

    Recruiting

  • Weinan Central Hospital

    Weinan

    Jianzhong Ma

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan

    Mian Peng

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Jianrui Lv

    Recruiting

  • Qinhai Provincial People's Hospital

    Xining, Qinghai

    Yun Wang

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Xinli Ni

    Recruiting

  • People's Hospital of Zhanjiang

    Zhanjiang

    Tao Tao

    Recruiting

  • People's Hospital of Zhengzhou University

    Zhengzhou

    Jiaqiang Zhang

    Recruiting

  • Traditional Chinese Medicine Hospital of Henan

    Zhengzhou

    Xihua Lu

    Recruiting

Other trials in China

About this study

Official title: Correlation Between Postoperative Cognitive Function and EEG Parameters in Elderly Patients Undergoing Non-cardiac Major Surgery : Multi-center, Prospective, Observational Study

In the elderly patients undergoing elective non-cardiac major surgery, the differences of EEG parameters between those with and without postoperative cognitive dysfunction were observed to determine the characteristic changes of EEG parameters related to postoperative cognitive dysfunction

Being tested
EEG(Electroencephalogram) change
Keywords
noncardiac surgery, elderly patients, postoperative cognitive dysfunction, Electroencephalogram
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.

  • EEG(Electroencephalogram) changeOther

    patients are found to have characteristic EEG change

Study groups in NCT04219033
Study groupRoleWhat they receive
with postoperative cognitive dysfunctionNot described
Receives: Other: EEG(Electroencephalogram) change
without postoperative dysfunctionNot described
Receives: Other: EEG(Electroencephalogram) change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery

    The difference (OR) between the miss rate of delta wave in patients with and without cognitive function change 1 day after operation.

    Measured: from end of surgery to 1 day after surgery

  2. The difference of spindle miss rate between patients with or without cognitive dysfunction by 1day after surgery

    The difference (OR) between the miss rate of spindle in patients with and without cognitive function change 1 day after operation.

    Measured: from end of surgery to 1 day after surgery

Secondary outcomes (12)

  1. The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 day after surgery

  2. The difference of spindle miss rate between patients with or without cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  3. The difference of burst suppression rate between patients with or without cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  4. correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 1 day after surgery

    Measured: from end of surgery to 1 day after surgery

  5. correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  6. correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery

    Measured: from end of surgery to 1d after surgery

  7. correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  8. correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery

    Measured: from end of surgery to 1 day after surgery

  9. correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 3 days after surgery

    Measured: from end of surgery to 3 days after surgery

  10. correlation of burst suppression rate and incidence of death by 30 days after surgery

    Measured: from end of surgery to 30 days after surgery

  11. correlation of delta wave miss rate and incidence of death by 30 days after surgery

    Measured: from end of surgery to 30 days after surgery

  12. correlation of spindle miss rate and incidence of death by 30 days after surgery

    Measured: from end of surgery to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2020
  2. Study start5 May 2020
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04219033
Sponsor's protocol ID
XJH-A-20190726
Acronym
POEM
Status last verified
Oct 2022
First submitted
31 Dec 2019
Last updated
18 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci. 2016 Oct 18;17(11):705-717. doi: 10.1038/nrn.2016.128.

    PubMed 27752068

  • Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.

    PubMed 18156878

  • Abildstrom H, Rasmussen LS, Rentowl P, Hanning CD, Rasmussen H, Kristensen PA, Moller JT. Cognitive dysfunction 1-2 years after non-cardiac surgery in the elderly. ISPOCD group. International Study of Post-Operative Cognitive Dysfunction. Acta Anaesthesiol Scand. 2000 Nov;44(10):1246-51. doi: 10.1034/j.1399-6576.2000.441010.x.

    PubMed 11065205

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Postoperative Cognitive Dysfunction, run by Air Force Military Medical University, China at 18 sites 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 4 inclusion and 4 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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?

Contact Hailong Dong (862984775337, hldong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery (time frame: from end of surgery to 1 day after surgery). The study lists 2 primary outcomes in all. 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 NCT04219033, which also lists 3 linked publications.

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 18 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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