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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06466083
Other study ID # 19880416
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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