GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction; Abdominal Neoplasm; Geriatrics; Hemodynamics
• Intervention / Treatment: Device: Masimo Root Hemodynamic Monitoring

Detailed Description

Postoperative neurocognitive disorders, including early postoperative cognitive decline, represent a significant source of morbidity in geriatric patients undergoing major abdominal cancer surgery. These impairments are multifactorial and are thought to arise from the interaction of perioperative hemodynamic instability, impaired cerebral autoregulation, systemic inflammatory responses, and age-related reductions in physiological reserve.

Among perioperative factors, intraoperative fluid management plays a central role in maintaining adequate tissue perfusion and organ function. Both hypovolemia and fluid overload have been associated with adverse outcomes, including impaired microcirculatory perfusion and potential effects on cerebral oxygen delivery. Traditional fluid management strategies, typically based on fixed formulas and static physiological parameters, may not adequately reflect inter-individual variability, particularly in elderly patients with altered cardiovascular compliance and limited adaptive capacity.

Goal-directed fluid therapy (GDFT) has emerged as an individualized hemodynamic management strategy aimed at optimizing stroke volume and tissue perfusion through the use of dynamic indicators of fluid responsiveness. While randomized trials and meta-analyses have demonstrated that GDFT can improve perioperative outcomes such as complication rates and length of hospital stay, its impact on postoperative cognitive outcomes remains insufficiently characterized, especially in oncologic geriatric populations.

Recent advances in non-invasive hemodynamic monitoring technologies, including the use of pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the need for invasive cardiac output monitoring. These tools offer a practical and safer alternative in routine clinical practice, particularly in elderly patients where invasive monitoring may not always be feasible.

This study is designed as a prospective observational cohort study conducted in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to standard clinical practice, and intraoperative fluid management strategy-either PVI/PI-guided GDFT or conventional fluid therapy-is determined by the attending anesthesiologist. No intervention is assigned by the study protocol, and no modification of routine clinical care is performed.

The primary objective of the study is to evaluate the association between intraoperative fluid management strategy and postoperative cognitive trajectory. Cognitive function is assessed using the Mini-Mental State Examination (MMSE) at three time points: preoperatively (baseline), postoperative day 1, and postoperative day 7. The primary outcome is defined as the change in MMSE scores over time.

To appropriately account for repeated cognitive measurements and potential confounding, longitudinal statistical models will be employed. Specifically, mixed-effects modeling will be used to evaluate the interaction between time and fluid management strategy, while adjusting for clinically relevant covariates, including age, ASA physical status, duration of surgery, and intraoperative blood loss.

Secondary objectives include evaluating the association between fluid management strategy and intraoperative physiological parameters, including total fluid administered, mean arterial pressure, heart rate, estimated blood loss, and net fluid balance.

Given the observational nature of the study, results will be interpreted as associations rather than causal effects. The study aims to generate clinically relevant evidence regarding whether individualized, non-invasive, goal-directed fluid strategies are associated with improved early postoperative cognitive recovery and optimized perioperative physiological stability in geriatric surgical patients.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06200
      • Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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; Use of PVI and PI parameters to guide intraoperative fluid titration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Intraoperative Fluid Volume	Total volume of intravenous fluids administered during surgery, including crystalloids, colloids, and blood products.	From induction of anesthesia to the end of surgery (assessed intraoperatively, up to approximately 4 hours)
Intraoperative Mean Arterial Pressure (MAP)	Mean arterial pressure values recorded at predefined intraoperative time points to assess hemodynamic stability	Baseline (pre-induction), intraoperative 1st hour, intraoperative 2nd hour
Intraoperative Heart Rate (HR)	Heart rate measurements recorded during surgery as an indicator of cardiovascular response	Intraoperative period (baseline, 1st hour, 2nd hour)
Estimated Blood Loss	Total estimated intraoperative blood loss recorded by the anesthesia and surgical team	Intraoperative period
Net Fluid Balance	Difference between total fluid input (intravenous fluids) and output (urine output and estimated blood loss).	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).
Change in Mean Arterial Pressure Over Time	Longitudinal change in MAP across intraoperative time points to evaluate hemodynamic trends	Baseline, intraoperative 1st hour, intraoperative 2nd hour

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Pathological Conditions, Signs and Symptoms; Postoperative Cognitive Complications; Abdominal Neoplasms
• Other Study ID Numbers: 2024-11/723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as per the ethical committee approval and institutional policies. Only aggregated study results will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No