Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06466096 |
| Other study ID # |
27961988 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 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 is a prospective cohort study to explore the differences of resting-state functional
magnetic resonance imaging (fMRI) between elderly gastrointestinal neoplasms patients with
postoperative delirium (POD) who either develop or do not develop long-term postoperative
neurocognitive disorders (pNCD).
Description:
The purpose of this study is to explore the differences of resting-state functional magnetic
resonance imaging (fMRI) between elderly gastrointestinal neoplasms patients with
postoperative delirium (POD) who either develop or do not develop long-term postoperative
neurocognitive disorders (pNCD).
Elderly gastrointestinal neoplasms patients aged 65 and above, undergoing surgical operations
at Xuanwu Hospital, Capital Medical University, were selected. All patients underwent
baseline fMRI scan before surgery, and their neurocognitive function was assessed using the
Montreal Cognitive Assessment (MoCA) within 1 week before surgery. General patient data such
as sex, age, comorbidities, BMI, ASA classification, and MoCA scores were collected. Under
routine anesthetic management of the Department of Anesthesiology and Surgical Operations at
Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Intraoperative
monitoring included heart rate, blood pressure, pulse oximetry, and body temperature, with
surgery and anesthesia times, and fluid balance recorded. Within 7 days post-surgery,
delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying
patients into POD and non-POD groups.For the patients in the POD group, neurocognitive
function was assessed at a period of time after surgery to determine the presence of pNCD,
further dividing the POD group into pNCD and non-pNCD subgroups, followed by fMRI scanning.
Differences of FC in fMRI were compared between patients with POD who did or did not develop
postoperative neurocognitive dysfunction. 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.
