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Comparison of the effects of arterial blood pressure and cardiac output based hemodynamic management on cognitive function in elderly patients undergoing spinal surgery: A Randomized Clinical Trial.

Comparison of the effects of arterial blood pressure and cardiac output based hemodynamic management on cognitive function in patients over 60 years old undergoing spinal surgery: A Randomized Clinical Trial.

Sponsor

Istanbul medical faculty

Enrollment

60 participants

Start Date

Apr 15, 2019

Study Type

Interventional

Conditions

Spinal surgery

Summary

We hypothesize that cardiac index based hemodynamic management can provide better postoperative cognitive function compared with arterial pressure-based hemodynamic management in elderly patients. Also, we expect cerebral oximetry desaturation will be less in the cardiac index group. Montreal Cognitive Assessment (cognitive function test) test will apply patients one day before surgery and seven days after surgery. Patients will be randomized to either a Cardiac index group (We will aim to maintain Cardiac index value within ± 20% of the baseline value that measured before anesthesia induction) or an arterial pressure group (Hemodynamic management will be made according to mean arterial pressure and systolic arterial pressure values. We will aim to maintain mean arterial pressure and systolic arterial pressure values within ± 20% of the baseline values that measured before anesthesia induction). In both group, entropy (depth of anesthesia) and cerebral oximeter will be measured. Anesthesia level will be adjust according to state entropy value. Target value is 40 to 60. In both groups, researchers who follow patients and record hemodynamic data will be blind to cerebral oximetry monitorization. Cerebral oximetry will be recorded by another researcher.

Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is examining how best to manage blood pressure and blood flow during spinal surgery in elderly patients, with the goal of protecting brain function after the operation. A known risk of surgery in older adults is postoperative cognitive decline — where thinking, memory, and mental clarity are noticeably worse after the procedure. Researchers believe that carefully controlling how much blood the heart pumps (cardiac output) during surgery may be better for the brain than simply controlling blood pressure. Patients aged 60 and over who are undergoing spinal surgery will be randomly assigned to one of two groups: one where the anaesthetic team maintains blood pressure within a target range, and another where they maintain the heart's pumping output within a target range. Both groups will also have brain oxygen levels monitored non-invasively. Cognitive tests will be given the day before surgery and again one week after. You may be eligible if you are 60 or older and scheduled for spinal surgery. People with epilepsy, a history of brain surgery, carotid artery narrowing, or fluid on the brain (hydrocephalus) cannot participate. This research could help improve how anaesthesia is managed in elderly surgical patients to protect their thinking and memory.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

We will make cardiac output and stroke volume measurement during surgery with FloTrac pulse conture cardiac output sensor ( Edwards Lifesciences, Irvine, CA, USA) using right or left radial artery cannulation. Hemodynamic management will be made according to Cardiac index value. We will aim to maintain Cardiac index value within ± 20% of the baseline value that measured before anesthesia induction. Intervention is the measurement of cardiac index and management of hemodynamics of patients according to the cardiac index value. The intervention will start before surgery and will continue until surgery finished. The intervention will be made by one of the researchers. Treatment of inadequate cardiac index will be included infusion of crystalloid solution, administration of bolus ephedrine sulfate (5mg) and noradrenaline infusion with start dose of 0.02 mcg/kg/min (if the infusion of crystalloid and administration of ephedrine will be insufficient)

Locations(1)

istanbul, Turkey

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