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

Completed

• Conditions: Anesthesia; Covert Stroke

• Registration Number: NCT03081429
• Lead Sponsor: Beijing Tiantan 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-16
• Study Start: 2018-05-23
• Primary Completion: 2022-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 934

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of perioperative stroke	Postoperative 1-7 days	Stroke is diagnosed by MRI

Secondary Outcome Measures

Name	Time	Method
The incidence of comorbidity.	30 days and 3 months after surgery	The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.
Recovery quality	1 day before surgery; and 7 days, 30 days, 3 months after surgery	The Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.
The quality of life	1 day before surgery; and 7 days, 30 days, 3 months after surgery	The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.
Postoperative cognitive function	1 day before surgery; and 7 days, 3 months, 1 year after surgery	Cognitive 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 state	1 day before surgery; and 7 days, 30 days, 3 months after surgery	Depression state will be assessed with the Geriatric Depression Scale, Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9.
Postoperative delirium	twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days	The 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.

Trial Locations

Locations (2)

Beijing TianTan Hospital; 🇨🇳 Beijing, China

Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, China