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

Recruiting

• Conditions: Postoperative Delirium; Anesthesia
• Interventions: Other: The regional cerebral oxygen saturation (rSO2); Other: The glial fibrillary acidic protein (GFAP); Other: The brain-derived-neurotrophic factor (BDNF)

• Registration Number: NCT05177159
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-04
• Study Start: 2018-11-10
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 417

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative delirium	The glial fibrillary acidic protein (GFAP)	-
Non postoperative delirium	The brain-derived-neurotrophic factor (BDNF)	-
Postoperative delirium	The regional cerebral oxygen saturation (rSO2)	-
Postoperative delirium	The brain-derived-neurotrophic factor (BDNF)	-
Non postoperative delirium	The regional cerebral oxygen saturation (rSO2)	-
Non postoperative delirium	The glial fibrillary acidic protein (GFAP)	-

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium within postoperative 5 days	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China