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

Air Force Military Medical University, China18 sites in 1 country1,250 target enrollmentMay 5, 2020

ConditionsAging Postoperative Cognitive Dysfunction EEG With Periodic Abnormalities

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aging
Sponsor: Air Force Military Medical University, China
Enrollment: 1250
Locations: 18
Primary Endpoint: The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 5, 2020

End Date

April 30, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Air Force Military Medical University, China

Responsible Party

Principal Investigator

Zhihong LU

professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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;

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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 burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery(from end of surgery to 1 day after surgery)
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)
correlation of spindle miss rate and incidence of death by 30 days after surgery(from end of surgery to 30 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 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 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)