Postoperative Cognitive Function and EEG (POEM)

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: Recruiting
• Conditions: Postoperative Cognitive Dysfunction; Aging; EEG With Periodic Abnormalities
• Intervention / Treatment: Other: EEG(Electroencephalogram) change

• Study Type: Observational
• Enrollment (Anticipated): 1250

Contacts and Locations

• Study Contact: Name: Hailong Dong; Phone Number: 862984775337; Email: hldong6@hotmail.com
• 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: Min Yan; Phone Number: 0571-87767223; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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	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	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

Outcome Measure	Time Frame
The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days 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	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	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	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	from end of surgery to 3 days after surgery
correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 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	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	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	from end of surgery to 3 days after surgery
correlation of burst suppression rate and incidence of death by 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	from end of surgery to 30 days after surgery
correlation of spindle miss rate and incidence of death by 30 days after surgery	from end of surgery to 30 days after surgery

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2020
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (ACTUAL): January 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Electroencephalogram; postoperative cognitive dysfunction; noncardiac surgery; elderly patients
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID 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