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

February 14, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

417

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population will be selected from patients who schedule to receive elective non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postoperative delirium
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
Other: 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.
Other: 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.
Non postoperative delirium
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
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative delirium within postoperative 5 days
Time Frame: the 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.
the incidence of delirum within postoperative 5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2018

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-5-30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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