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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000471189

Enrollment

Registered

2019-03-21

Start date

2019-04-15

Completion date

2019-06-30

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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)

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

1-age equal or over 60 years 2-patients who undergo spinal surgery

Exclusion criteria

1-not have epilepsy 2-not undergo brain surgery before 3-not have carotid stenosis 4-not have hydrocephalus

Outcome results