Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Postoperative Cognitive Function (MMSE Scores)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Masimo Root Hemodynamic Monitoring (Device)
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
结局指标
主要结局
Change in Postoperative Cognitive Function (MMSE Scores)
时间窗: Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.
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.
次要结局
- 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).)
- Change in Mean Arterial Pressure Over Time(Baseline, intraoperative 1st hour, intraoperative 2nd hour)
研究者
Mustafa Kemal ŞAHİN
Principal Investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital