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NCT Number: NCT03081429

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

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.

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Key information

Conditions

Anesthesia Covert Stroke

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing TianTan Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The incidence of perioperative stroke

    Time frame: Postoperative 1-7 days

    Stroke is diagnosed by MRI

Secondary outcomes

  1. Postoperative cognitive function

    Time frame: 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.

  2. Postoperative delirium

    Time frame: 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.

  3. Recovery quality

    Time frame: 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.

  4. The quality of life

    Time frame: 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.

  5. Depression state

    Time frame: 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.

  6. The incidence of comorbidity.

    Time frame: 30 days and 3 months after surgery

    The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Official study title

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

Acronym: PRECISION

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Mar 16, 2017
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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