Postoperative Cognitive Function and EEG (POEM)

October 15, 2022 updated by: Zhihong LU, Air Force Military Medical University, China

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhihong Lu
  • Phone Number: 8613891975018 8613891975018
  • Email: deerlu23@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Jing Zhao
      • Chongqing, China
        • Recruiting
        • Xinqiao Hospital of Army Medical University
      • Nanjing, China
        • Recruiting
        • People's Hospital of Jiangsu
        • Contact:
          • Cunming Liu
      • Weinan, China
        • Recruiting
        • Weinan Central Hospital
        • Contact:
          • Jianzhong Ma
      • Wuhan, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Mian Peng
      • Zhanjiang, China
        • Recruiting
        • People's Hospital of Zhanjiang
        • Contact:
          • Tao Tao
      • Zhengzhou, China
        • Recruiting
        • People's Hospital of Zhengzhou University
      • Zhengzhou, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Henan
        • Contact:
          • Xihua Lu
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • Suzhou First People's Hospital
        • Contact:
          • Fuhai Ji
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital Nanchang University
        • Contact:
          • Shibiao Chen
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • General Hospital of Northern Theater Command
        • Contact:
          • Yugang Diao
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Xinli Ni
    • Qinghai
      • Xining, Qinghai, China
        • Recruiting
        • Qinhai Provincial People's Hospital
        • Contact:
          • Yun Wang
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jianrui Lv
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
          • Chongfang Han
      • Taiyuan, Shanxi, China
        • Recruiting
        • First Hospital of ShanXi Medical University
        • Contact:
          • Shouyuan Tian
      • Taiyuan, Shanxi, China
        • Recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
          • Linzhong Zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 100 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1150 cases in the elderly group and 100 cases in the adult background group

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. patients with central nervous system diseases and mental diseases
  2. preoperative minimal mental status examination(MMSE) score<24;
  3. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
with postoperative cognitive dysfunction
Other: EEG(Electroencephalogram) change
patients are found to have characteristic EEG change
without postoperative dysfunction
Other: EEG(Electroencephalogram) change
patients are found to have characteristic EEG change

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
from end of surgery to 1 day after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
from end of surgery to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJH-A-20190726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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