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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177159
• Other study ID #: 2018-5-30
• Status: Recruiting
• Start date: November 10, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Beijing Tiantan Hospital
• Contact: Zhengfang Hu, M.D., Ph.D
• Phone: 8610-67096658
• Email: huzhengfang78[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 417
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• With American Society of Anesthesiologists (ASA) physical status ?-?
• 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

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Postoperative Delirium

Intervention

Other:
• The 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
• The 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.
• The 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	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 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.