Postoperative Cognitive Function and EEG

Recruiting

• Conditions: Postoperative Cognitive Dysfunction; Aging; EEG With Periodic Abnormalities

• Registration Number: NCT04219033
• Lead Sponsor: Air Force Military Medical University, China

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2020-05-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-15
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (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, China

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