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COMPLETED
NCT07438249

GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery

Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

View on ClinicalTrials.gov

Summary

Postoperative cognitive decline remains a common and clinically significant complication among geriatric patients undergoing major abdominal cancer surgery. Age-related physiological vulnerability, impaired cerebral autoregulation, and perioperative hemodynamic instability contribute to the development of postoperative neurocognitive impairment. Goal-directed fluid therapy (GDFT), guided by dynamic hemodynamic parameters, has been proposed as an individualized approach to optimize tissue perfusion while avoiding both hypovolemia and fluid overload. Non-invasive monitoring technologies, such as pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the risks associated with invasive monitoring, making them particularly suitable for elderly surgical populations. This prospective observational cohort study aims to evaluate the association between intraoperative PVI/PI-guided GDFT and postoperative cognitive outcomes in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to routine clinical practice, either with individualized GDFT or conventional fluid therapy, as determined by the attending anesthesiologist. The primary outcome is the change in cognitive function, assessed using Mini-Mental State Examination (MMSE) scores from baseline to postoperative day 1 and postoperative day 7. Longitudinal changes in cognitive function will be analyzed using adjusted statistical models to account for repeated measurements over time and potential confounding factors, including age, ASA physical status, duration of surgery, and intraoperative blood loss. Secondary outcomes include intraoperative fluid administration, hemodynamic parameters, estimated blood loss, and net fluid balance. The study is designed to provide clinically relevant evidence on whether individualized, non-invasive hemodynamic monitoring strategies are associated with improved perioperative physiological stability and early postoperative cognitive recovery in elderly surgical patients.

Official title: Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2024-12-01

Completion Date

2026-03-30

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DEVICE

Masimo Root Hemodynamic Monitoring

Use of PVI and PI parameters to guide intraoperative fluid titration.

Locations (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, Turkey (Türkiye)