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A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction

A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03081429
Acronym
PRECISION
Enrollment
934
Registered
2017-03-16
Start date
2018-05-23
Completion date
2023-08-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Covert Stroke

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.

Interventions

None listed

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of perioperative strokePostoperative 1-7 daysStroke is diagnosed by MRI

Secondary

MeasureTime frameDescription
Postoperative deliriumtwice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 daysThe Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) or 3 min diagnostic interview for CAM (3D-CAM) will be applied to assess delirium.
Recovery quality1 day before surgery; and 7 days, 30 days, 3 months after surgeryThe Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.
Postoperative cognitive function1 day before surgery; and 7 days, 3 months, 1 year after surgeryCognitive assessment will be conducted by trained research members who are blinded to the clinical diagnosis, treatment and MRI. The Mini-mental State Examination, Montreal cognitive assessment-basic, Mini-Mental State Examination telephone scales, Montreal Cognitive Assessment telephone scales, and Telephone Interview of Cognitive Status scale will be used to assess the cognitive function. Postoperative cognitive dysfunction is defined as at least 2 standard deviation reduction on the Mini-Mental State Examination telephone scales or Montreal Cognitive Assessment telephone scales or a Telephone Interview of Cognitive Status scale scores≤27.
Depression state1 day before surgery; and 7 days, 30 days, 3 months after surgeryDepression state will be assessed with the Geriatric Depression Scale, Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9.
The incidence of comorbidity.30 days and 3 months after surgeryThe incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.
The quality of life1 day before surgery; and 7 days, 30 days, 3 months after surgeryThe quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026