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GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery

NCT07438249 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Postoperative Cognitive Dysfunction
  • Geriatrics
  • Abdominal Neoplasm
  • Hemodynamics

Interventions

DEVICE

Masimo Root Hemodynamic Monitoring

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

Sponsors & Collaborators

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-01
Completion
2026-03-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438249 on ClinicalTrials.gov