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
1 other identifier
observational
1,250
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2019
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedStudy Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedOctober 18, 2022
October 1, 2022
2.9 years
December 31, 2019
October 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
with postoperative cognitive dysfunction
without postoperative dysfunction
Interventions
patients are found to have characteristic EEG change
Eligibility Criteria
1150 cases in the elderly group and 100 cases in the adult background group
You may qualify if:
- 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
You may not qualify if:
- patients with central nervous system diseases and mental diseases
- preoperative minimal mental status examination(MMSE) score\<24;
- ASA status III or higher
- \) 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Suzhou First People's Hospital
Suzhou, Jiangsu, China
The First Affiliated Hospital Nanchang University
Nanchang, Jiangxi, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinhai Provincial People's Hospital
Xining, Qinghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
China-Japan Friendship Hospital
Beijing, China
Xinqiao Hospital of Army Medical University
Chongqing, China
People's Hospital of Jiangsu
Nanjing, China
Weinan Central Hospital
Weinan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
People's Hospital of Zhanjiang
Zhanjiang, China
People's Hospital of Zhengzhou University
Zhengzhou, China
Traditional Chinese Medicine Hospital of Henan
Zhengzhou, China
Related Publications (3)
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.
PMID: 27752068RESULTMonk 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.
PMID: 18156878RESULTAbildstrom 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.
PMID: 11065205RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 31, 2019
First Posted
January 6, 2020
Study Start
May 5, 2020
Primary Completion
March 31, 2023
Study Completion
April 30, 2023
Last Updated
October 18, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share