Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Surgery
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective, randomized, controlled clinical trial.Masking: Double (Participant, Outcomes Assessor)Masking Description: Subjects will be randomly allocated to either interventional or control group according to a computer generated randomization code in predetermined size blocks. Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. The NIRS screen will be concealed in the control group to ensure blinding.Primary Purpose: Prevention

Participation Requirements

Age
Between 61 years and 100 years
Gender
Both males and females

Description

With the increase in life expectancy observed in the last decades, the number of aged patients requiring general anesthesia for major non-cardiac surgery, such as abdominal, pelvic, and thoracic surgeries has increased dramatically. This patient population is at increased risk of postoperative compl...

With the increase in life expectancy observed in the last decades, the number of aged patients requiring general anesthesia for major non-cardiac surgery, such as abdominal, pelvic, and thoracic surgeries has increased dramatically. This patient population is at increased risk of postoperative complications due to the presence of multiple comorbidities and reduced physiological reserve. One of the largest prospective studies of over 4000 patients aged 70 years and over undergoing major non-cardiac surgery identified that 68% of these patients had pre-existing comorbidities. Furthermore, the 30-day postoperative mortality was 5% and major postoperative complications were present in 20% of patients. The authors concluded that strategies are needed to reduce complications and mortality in older surgical patients. The primary goal of hemodynamic management during the surgical procedure is to ensure adequate perfusion and oxygen delivery to the vital organs. In the last decade, technological research has expanded the application of near infrared spectroscopy (NIRS) to allow continuous non-invasive monitoring of cerebral oxygen saturation, providing information on the real time status on the balance between brain oxygen supply and demand. Furthermore, NIRS provides extra assurance of the adequacy of global oxygen balance, particularly focusing on the venous side of the circulation. Moreover several studies have demonstrated that changes in cerebral tissue oxygenation may correlate with changes in cerebral blood flow when cerebral metabolic rate of oxygen and arterial blood oxygen content remain constant. With the current standards of monitoring that primarily focus on the left heart, i.e., oxygen supply, and not the imbalance between oxygen supply/demand, the vital organ ischemia may go unnoticed until functional organ damage becomes evident. Regional cerebral oxygen saturation (rSO2) provides a non-invasive alternative of adequacy of systemic oxygen balance that correlates well with a gold standard of mixed venous oxygen saturation. Cerebral desaturations have been reported in more than 20% of cases when monitoring regional cerebral oxygen saturation (rSO2) in elderly patients undergoing non-cardiac abdominal surgery. Low rSO2 values have been associated with postoperative cognitive dysfunction (POCD), perioperative stroke, increased incidence of major organ morbidity, and even 30-day and 1-year mortality after cardiac surgery. Furthermore, low preoperative rSO2 measurements have been associated with higher risk of postoperative delirium in both cardiac and non-cardiac surgical populations. The proposed trial will be the first large prospective randomized controlled clinical trial assessing the effectiveness of rSO2 restoration in reducing postoperative morbidity associated with end organ dysfunction after major non-cardiac surgery.

Tracking Information

NCT #
NCT04627506
Collaborators
Not Provided
Investigators
Principal Investigator: Lian Kah Ti National University Health System