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

Anesthesia Clinical Trial

— PRECISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081429
• Other study ID #: 2017-3-10
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the development of population aging, the incidence of covert stroke and cognitive dysfunction 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 dysfunction. 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 dysfunction in elderly patients undergoing noncardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 934
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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, and cannot complete the cognitive evaluation and refuse to sign informed consent will be excluded from the trial.

Related Conditions & MeSH terms

• Anesthesia
• Cognitive Dysfunction
• Covert Stroke
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Stroke

Locations

Country	Name	City	State
China	Beijing TianTan Hospital	Beijing
China	Chinese People's Liberation Army General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of perioperative covert stroke	Stroke is diagnosed by MRI	Postoperative 3-7 days
Secondary	Postoperative cognitive function	Cognitive assessment will be conducted by trained research members who are blinded to the clinical diagnosis, treatment and MRI. The Mini-mental State Examination (MMSE) and Montreal cognitive assessment-basic (MoCA-B) will be used to assess the cognitive function. Postoperative cognitive dysfunction is defined as at least 2 standard deviation reduction in either assessment of MMSE or MoCA-B.	1 day before surgery; and 3 months, 1 year after surgery
Secondary	Postoperative delirium	The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) will be applied to assess delirium.	4 hours, 24 hours, and 7 days after surgery
Secondary	Recovery quality	The Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.	1 day before surgery; and 30 days, 3 months after surgery
Secondary	The quality of life	The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.	1 day before surgery; and 30 days, 3 months after surgery
Secondary	Depression state	Depression state will be assessed with the Geriatric Depression Scale.	1 day before surgery; and 30 days, 3 months after surgery
Secondary	The incidence of comorbidity.	The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.	30 days and 3 months after surgery