Clinical trial NCT04219033: Postoperative Cognitive Function and EEG
Official title: Correlation Between Postoperative Cognitive Function and EEG Parameters in Elderly Patients Undergoing Non-cardiac Major Surgery : Multi-center, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Postoperative Cognitive Dysfunction
EEG With Periodic Abnormalities
Keywords: noncardiac surgery
elderly patients
postoperative cognitive dysfunction
Electroencephalogram
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 1250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1150 cases in the elderly group and 100 cases in the adult background group

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


Eligibility criteria: 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;

Primary outcomes:
measure: The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery
timeFrame: from end of surgery to 1 day after surgery
measure: The difference of spindle miss rate between patients with or without cognitive dysfunction by 1day after surgery
timeFrame: from end of surgery to 1 day after surgery
Secondary outcomes:
measure: The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 day after surgery
measure: The difference of spindle miss rate between patients with or without cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: The difference of burst suppression rate between patients with or without cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 1 day after surgery
timeFrame: from end of surgery to 1 day after surgery
measure: correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery
timeFrame: from end of surgery to 1d after surgery
measure: correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery
timeFrame: from end of surgery to 1 day after surgery
measure: correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 3 days after surgery
timeFrame: from end of surgery to 3 days after surgery
measure: correlation of burst suppression rate and incidence of death by 30 days after surgery
timeFrame: from end of surgery to 30 days after surgery
measure: correlation of delta wave miss rate and incidence of death by 30 days after surgery
timeFrame: from end of surgery to 30 days after surgery
measure: correlation of spindle miss rate and incidence of death by 30 days after surgery
timeFrame: from end of surgery to 30 days after surgery
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xining
country: China
facility: Qinhai Provincial People's Hospital
state: Qinghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Chongqing
country: China
facility: Xinqiao Hospital of Army Medical University
city: Nanjing
country: China
facility: People's Hospital of Jiangsu
city: Weinan
country: China
facility: Weinan Central Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Zhanjiang
country: China
facility: People's Hospital of Zhanjiang
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Traditional Chinese Medicine Hospital of Henan
Study officials:
References:
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.
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. doi: 10.1097/01.anes.0000296071.19434.1e.
citation: 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 Anaesthesiol Scand. 2000 Nov;44(10):1246-51. doi: 10.1034/j.1399-6576.2000.441010.x.