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.
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
- Conditions the study is for
- Aging, Postoperative Cognitive Dysfunction, EEG With Periodic Abnormalities
- 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.
18 sites in 1 country
China18 sites, 18 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| with postoperative cognitive dysfunction | Not described Receives: Other: EEG(Electroencephalogram) change | |
| without postoperative dysfunction | Not described Receives: Other: EEG(Electroencephalogram) change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery
Measured: from end of surgery to 1d after surgery
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
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
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
correlation of burst suppression rate and incidence of death by 30 days after surgery
Measured: from end of surgery to 30 days after surgery
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
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.
- First posted6 Jan 2020
- Study start5 May 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
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 27752068Monk 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 18156878Abildstrom 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Cognitive Function and EEG Parameters in Elderly Patients Undergoing Non-cardiac Major Surgery : Multi-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT04219033
- Acronym / sponsor ID
- POEM / XJH-A-20190726
- Keywords
- noncardiac surgery, elderly patients, postoperative cognitive dysfunction, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 6 Jan 2020 (actual)
- 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with postoperative cognitive dysfunction | – | Other: EEG(Electroencephalogram) change |
| without postoperative dysfunction | – | Other: EEG(Electroencephalogram) change |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 1150 cases in the elderly group and 100 cases in the adult background group
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG(Electroencephalogram) changepatients are found to have characteristic EEG change | Other | with postoperative cognitive dysfunction, without postoperative dysfunction |
Primary outcome
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 difference (OR) between the miss rate of delta wave in patients with and without cognitive function change 1 day after operation.
The difference of spindle miss rate between patients with or without cognitive dysfunction by 1day after surgery
Time frame: from end of surgery to 1 day after surgery
The difference (OR) between the miss rate of spindle in patients with and without cognitive function change 1 day after operation.
12 secondary outcomes
The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 day after surgery
The difference of spindle miss rate between patients with or without cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery
The difference of burst suppression rate between patients with or without cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery
correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 1 day after surgery
Time frame: from end of surgery to 1 day after surgery
correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery
correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery
Time frame: from end of surgery to 1d after surgery
correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery
correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery
Time frame: from end of surgery to 1 day after surgery
correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery
correlation of burst suppression rate and incidence of death by 30 days after surgery
Time frame: from end of surgery to 30 days after surgery
correlation of delta wave miss rate and incidence of death by 30 days after surgery
Time frame: from end of surgery to 30 days after surgery
correlation of spindle miss rate and incidence of death by 30 days after surgery
Time frame: from end of surgery to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Results publication: PubMed 27752068Vutskits 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.
- Results publication: PubMed 18156878Monk 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.
- Results publication: PubMed 11065205Abildstrom 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.
- Individual participant dataSharing planned: No
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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.
18 sites in 1 country: see every site and its status.
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.