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Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.

Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05177159
Enrollment
417
Registered
2022-01-04
Start date
2018-11-10
Completion date
2023-12-30
Last updated
2023-02-15

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

Conditions

Anesthesia, Postoperative Delirium

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.

Interventions

OTHERThe regional cerebral oxygen saturation (rSO2)

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

OTHERThe glial fibrillary acidic protein (GFAP)

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.

OTHERThe brain-derived-neurotrophic factor (BDNF)

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.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative delirium within postoperative 5 daysthe incidence of delirum 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.

Countries

China

Contacts

Primary ContactZhengfang Hu, M.D., Ph.D
huzhengfang78@163.com8610-67096658

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026