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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04219033
Other study ID # XJH-A-20190726
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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