GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery

NCT07438249 | Completed

• 1 other identifier: 2024-11/723
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Cognitive Function (MMSE Scores)

  The primary outcome is the assessment of cognitive function using the Mini-Mental State Examination. The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, where lower scores indicate greater cognitive impairment (e.g., \<24 is typically considered indicative of cognitive dysfunction). The study will compare the incidence of POCD between the GDFT group (monitored via Masimo Root PVI/PI) and the conventional fluid therapy group.

  Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.

Secondary Outcomes (6)

• Total Intraoperative Fluid Volume

  From induction of anesthesia to the end of surgery (assessed intraoperatively, up to approximately 4 hours)

• Intraoperative Mean Arterial Pressure (MAP)

  Baseline (pre-induction), intraoperative 1st hour, intraoperative 2nd hour

• Intraoperative Heart Rate (HR)

  Intraoperative period (baseline, 1st hour, 2nd hour)

• Estimated Blood Loss

  Intraoperative period

• Net Fluid Balance

  From induction of anesthesia to the end of surgery (calculated at the end of surgery, over an intraoperative period of up to approximately 4 hours).

Study Arms (2)

GDFT Group (Masimo Root Guided)

Patients in this group will receive intraoperative GDFT. Hemodynamic monitoring will be performed using the Masimo Root device. Fluid administration (crystalloids and/or colloids) will be titrated based on real-time PVI and PI values to maintain optimal stroke volume and tissue perfusion. The goal is to achieve individualized hemodynamic stability throughout the major abdominal cancer surgery.

Device: Masimo Root Hemodynamic Monitoring

Conventional Group (Standard Care)

Patients in this group will receive conventional fluid therapy based on standard clinical guidelines. Fluid requirements will be calculated using the traditional "4:2:1" rule (physiological requirement + estimated blood loss + third-space fluid loss). Intraoperative fluid management will rely on routine monitoring (heart rate, mean arterial pressure, and urine output) without the use of advanced hemodynamic parameters like PVI or PI from the Masimo Root device

Interventions

Masimo Root Hemodynamic Monitoring DEVICE

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

GDFT Group (Masimo Root Guided)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of geriatric patients (aged 65 and older) scheduled for elective major abdominal cancer surgery at the University of Health Sciences, Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Participants will be selected from patients who meet the inclusion criteria and provide informed consent during their preoperative evaluation in the anesthesiology clinic

You may qualify if:

• Age ≥ 65 years (geriatric patients)
• Scheduled for elective major abdominal cancer surgery
• American Society of Anesthesiologists (ASA) Physical Status I-IV
• Eastern Cooperative Oncology Group (ECOG/WHO/Zubrod) performance status ≥ 2
• Ability to complete cognitive assessments
• Provision of written informed consent

You may not qualify if:

• Severe cardiac dysfunction (Cardiac Index ≤ 2.2 L/min/m²)
• History of neurological or psychiatric disorders (e.g., dementia, Alzheimer's disease)
• Use of medications that significantly affect cognitive function
• Severe hepatic or renal failure
• Prior chemotherapy or radiotherapy before surgery
• Intraoperative or perioperative blood transfusion
• Prolonged mechanical ventilation (inability to extubate immediately after surgery)
• Pre-existing cognitive impairment (baseline Mini-Mental State Examination \[MMSE\] score \< 24)

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (3)

• Wu B, Guo Y, Min S, Xiong Q, Zou L. Postoperative cognitive dysfunction in elderly patients with colorectal cancer: A randomized controlled study comparing goal-directed and conventional fluid therapy. Open Med (Wars). 2024 Mar 27;19(1):20240930. doi: 10.1515/med-2024-0930. eCollection 2024.

  PMID: 38584828 BACKGROUND

• Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.

  PMID: 29678619 BACKGROUND

• Zhang J, Qiao H, He Z, Wang Y, Che X, Liang W. Intraoperative fluid management in open gastrointestinal surgery: goal-directed versus restrictive. Clinics (Sao Paulo). 2012 Oct;67(10):1149-55. doi: 10.6061/clinics/2012(10)06.

  PMID: 23070341 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications; Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)