Clinical trial NCT03081429: A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction
Official title: A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Covert Stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2017-03-16
Enrollment: 934
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be selected from patients who schedule to receive elective noncardiac surgery in Beijing Tiantan Hospital and Chinese People's Liberation Army General Hospital.

Brief summary: With the development of population aging, the incidence of covert stroke gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive outcomes. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative cognitive outcomes in elderly patients undergoing noncardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were aged ≥60 years and scheduled for elective non-cardiac surgery with general anesthesia, with or without concomitant regional analgesia. They were expected to have surgery lasting at least 2 hours of anesthesia and to stay in the hospital at least 2 days thereafter.

Exclusion Criteria:

* Patients have MRI contraindications, cannot complete the cognitive evaluation, undergo carotid artery surgery or refuse to sign informed consent will be excluded from the trial.

Primary outcomes:
measure: The incidence of perioperative stroke
timeFrame: Postoperative 1-7 days
Secondary outcomes:
measure: Postoperative cognitive function
timeFrame: 1 day before surgery; and 7 days, 3 months, 1 year after surgery
measure: Postoperative delirium
timeFrame: twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days
measure: Recovery quality
timeFrame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
measure: The quality of life
timeFrame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
measure: Depression state
timeFrame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
measure: The incidence of comorbidity.
timeFrame: 30 days and 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TianTan Hospital
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
Study officials:
References:
citation: Cui Q, Wang D, Zeng M, Dong J, Jin H, Hu Z, Zhang Y, Peng Y, Han R. Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study). BMJ Open. 2020 Jan 6;10(1):e034657. doi: 10.1136/bmjopen-2019-034657.