Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients
NCT07736092
Confusion, Delayed Neurocognitive Recovery
Beijing, Beijing Municipality, China
View Trial DetailsNCT Number: NCT07369466
Objective: To investigate the association between preoperative hippocampal glucose metabolism levels and the risk of postoperative delirium (POD) in elderly patients with type 2 diabetes (T2DM), and to provide a prospective neuroimaging biomarker for identifying high-risk populations.
Methods: This prospective cohort study plans to enroll 154 elderly T2DM patients scheduled for liver tumor resection at the First Medical Center of Chinese PLA General Hospital. Baseline cognitive function will be assessed using the Mini-Mental State Examination (MMSE) one day before surgery. Hippocampal glucose metabolism will be quantitatively evaluated by measuring the mean standardized uptake value (SUVmean) of bilateral hippocampi using ¹⁸F-FDG PET/CT. POD will be assessed twice daily from postoperative days 1 to 7 using the 3-Minute Diagnostic Interview for CAM (3D-CAM). The correlation between preoperative hippocampal SUVmean and POD incidence will be analyzed using univariate and multivariate logistic regression models. The predictive performance will be evaluated by constructing receiver operating characteristic (ROC) curves. Furthermore, the relationship between a peripheral insulin resistance marker (the triglyceride-glucose index, TyG index) and hippocampal metabolism levels will be analyzed.
Significance: This study aims to determine whether impaired preoperative hippocampal metabolism serves as an independent risk factor for POD. The findings are expected to provide a prospective functional neuroimaging biomarker for the early warning of POD and offer a theoretical basis for developing precise prevention strategies targeting cerebral metabolic abnormalities. This will facilitate the application of neuroimaging techniques in the field of perioperative brain dysfunction monitoring.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From surgery completion to postoperative day 7
Assessed by the 3-Minute Diagnostic Interview for CAM (3D-CAM), administered twice daily.
Time frame: Within 7 days before surgery (preoperative baseline)
Calculated as Ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL) / 2].
Time frame: From surgery completion to postoperative day 30
Incidence of postoperative adverse events within 30 days, including but not limited to cardiovascular adverse events, ischemic stroke, pulmonary infection, acute kidney injury, and pain assessment.
Contact information is provided by the study sponsor or research team.
Danyang Geng, Master
CONTACT
86+17367522284
Weidong Mi, Professor
CONTACT
86+13381082966
Chinese PLA General Hospital
Other
Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07736092
Confusion, Delayed Neurocognitive Recovery
Beijing, Beijing Municipality, China
View Trial DetailsNCT07310043
Confusion, Delirium
View Trial DetailsNCT07695285
Confusion, Delirium
View Trial DetailsNCT07686900
Cardiac Surgical Procedures, Confusion
Nanjing, Jiangsu, China
View Trial Details