Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.
1 other identifier
observational
417
1 country
1
Brief Summary
Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedStudy Start
First participant enrolled
November 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedFebruary 15, 2023
February 1, 2023
5.1 years
June 4, 2018
February 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of postoperative delirium within postoperative 5 days
The postoperative delirium will be diagnosed if patients have fluctuation in mental status and attention and either thinking or consciousness in the past 24 hours as evidenced by fluctuation on Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale.
the incidence of delirum within postoperative 5 days.
Study Arms (2)
Postoperative delirium
Non postoperative delirium
Interventions
Measurement of rSO2 with non-invasive near-infrared light spectrum monitor. The average, left and right frontal regions absolute rSO2 values will be collected every 30 seconds during the whole surgery until postoperative 2 hours, and the mean values will be calculated. Absolute rSO2 value and AUT (area under the threshold) send beneath the absolute threshold limits of 40%, 50% and 20%, 30% under the baseline. AUT will be calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate
Venous blood sample will be collected and tested for plasma GFAP. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.
Venous blood sample will be collected and tested for plasma BDNF. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.
Eligibility Criteria
The population will be selected from patients who schedule to receive elective non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.
You may qualify if:
- With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
- Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
- Operation time is expected to be longer than 2 hours
You may not qualify if:
- Clinical diagnosis of dementia
- Clinical diagnosis of cerebrovascular disorders
- Clinical diagnosis of heart failure
- Clinical diagnosis of liver failure
- Clinical diagnosis of renal failure
- Clinical diagnosis of traumatic brain injury
- Alcohol abuse
- Can not complete the cognitive assessments
- Refuse to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruquan Han, M.D., Ph.D
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 4, 2018
First Posted
January 4, 2022
Study Start
November 10, 2018
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
February 15, 2023
Record last verified: 2023-02