Correlation Analysis of POD and PND in Elderly Spinal Surgery Patients Based on Rs-fMRI

Postoperative Delirium Clinical Trial

Official title:

Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Spinal Surgery Patients Based on Resting State Functional Magnetic Resonance Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466083
• Other study ID #: 19880416
• Status: Not yet recruiting
• Start date: June 14, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Xuanwu Hospital, Beijing
• Contact: lei zhao
• Phone: +8613811035886
• Email: zhaoalei[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is a prospective cohort study to investigate the differences in resting-state functional magnetic resonance imaging (fMRI) between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Description:

To investigate the differences in resting-state functional magnetic resonance imaging (fMRI) between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Neurocognitive function of the study participants was assessed within one week before surgery using the Montreal Cognitive Assessment (MoCA). Perform baseline MRI scan before surgery. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. Neurocognitive function assessments were conducted long-term after surgery for the POD group to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups, followed by fMRI scanning.By comparing the patterns and intensities of brain functional connectivity between the pNCD and non-pNCD subgroups, a differential analysis was conducted on the effective connectivity and information flow of functional networks, exploring the state of the brain functional network during the process of POD and pNCD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients =65 years of age who have undergone spinal surgery anesthesia; Sign informed consent

Exclusion Criteria:

• Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Neurocognitive Disorders
• Postoperative Delirium
• Spinal Surgery

Intervention

Other:
• no intervention
this is an observation study,no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Functional Connectivity between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery	Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.	2024.5.9-2026.5.1