Postoperative Cognitive Function and EEG

Aging Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219033
• Other study ID #: XJH-A-20190726
• Status: Recruiting
• Start date: May 5, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2022
• Source: Air Force Military Medical University, China
• Contact: Hailong Dong
• Phone: 862984775337
• Email: hldong6[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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;

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• EEG With Periodic Abnormalities
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Other:
• EEG(Electroencephalogram) change
patients are found to have characteristic EEG change

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing
China	Xinqiao Hospital of Army Medical University	Chongqing
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital Nanchang University	Nanchang	Jiangxi
China	People's Hospital of Jiangsu	Nanjing
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Suzhou First People's Hospital	Suzhou	Jiangsu
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	Weinan Central Hospital	Weinan
China	Zhongnan Hospital of Wuhan University	Wuhan
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Qinhai Provincial People's Hospital	Xining	Qinghai
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	People's Hospital of Zhanjiang	Zhanjiang
China	People's Hospital of Zhengzhou University	Zhengzhou
China	Traditional Chinese Medicine Hospital of Henan	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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 Anaesthesio — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery		from end of surgery to 1d after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	correlation of burst suppression rate and incidence of death by 30 days after surgery		from end of surgery to 30 days after surgery
Secondary	correlation of delta wave miss rate and incidence of death by 30 days after surgery		from end of surgery to 30 days after surgery
Secondary	correlation of spindle miss rate and incidence of death by 30 days after surgery		from end of surgery to 30 days after surgery