Cardiac and Renal Biomarkers in Arthroplasty Surgery

Study Overview
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Brief Summary
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The investigators will compare the effect of spinal anesthesia to general anesthesia on the level of high sensitivity cardiac biomarkers in patients undergoing hip or knee arthroplasty. The investigators will also measure renal biomarkers in urine to evaluate kidney injury in the postoperative period.

Detailed Description
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The study will enroll a total of 140 adult patients undergoing hip or knee arthroplasty (equal numbers) at Barnes-Jewish-Hospital. These procedures will be randomized with 50% of the procedures performed under spinal anesthesia and 50% procedures performed under general anesthesia. Patients randomized to spinal anesthesia will receive sedation with dexmedetomidine up to 1 mcg/kg/min, and then add small dose of propofol (up to 50 mcg/kg/min) and fentanyl at the discretion of the anesthesia provider the Richmond Agitation and Sedation Scale (RASS) -2 to -3. Headphones to play music will be offered to patients undergoing spinal anesthesia to minimize the noise generated from the surgical intervention. The investigators will study the effect of spinal anesthesia versus general anesthesia on cardiac biomarker levels in hip and knee arthroplasty population (levels of Hs-cTnI postoperatively compared to baseline values) Also, the incidence of postoperative renal injury using investigational renal biomarkers, Myo-Inositol Oxygenase (MIOX) and Nephrocheck

Official Title
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Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery

Conditions
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Renal Injury, Anesthesia, Myocardial Injury, Arthropathy of Knee, Arthropathy of Hip

Intervention / Treatment
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* Drug: Spinal Anesthesia
* Drug: General Anesthetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, age 60 years or older Ability to provide informed consent American Society of Anesthesiologists (ASA) classification II or higher Exclusion Criteria: Hip fracture procedures Contraindications to neuraxial anesthesia per The American Society of Regional Anesthesia (ASRA) guidelines Procedure anticipated duration is longer than expected planned spinal anesthesia duration

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Arthroplasty<br>Surgery to replace the knee joint with prothetic joint | Drug: Spinal Anesthesia<br>* Patients will be randomized to type of anesthesia<br>Drug: General Anesthetics<br>* Patients will be randomized to type of anesthesia<br>|
| Experimental: Hip Arthroplasty<br>Surgery to replace the hip joint with prothetic joint | Drug: Spinal Anesthesia<br>* Patients will be randomized to type of anesthesia<br>Drug: General Anesthetics<br>* Patients will be randomized to type of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively | Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit | Before discharge (approximately 24 hours after surgery) | 
| Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively | Hs-cTnI increase >50% above the sex-specific 99th percentile upper reference limit | at time of postoperative visit (around 2 weeks post discharge) | 
| Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | Before discharge (approximately 24 hours after surgery) | 
| Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | at time of postoperative visit (around 2 weeks post discharge) | 
| Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | at time of postoperative visit (around 2 weeks post discharge) | 
| Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | Before discharge (approximately 24 hours after surgery) | 
| Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | at time of postoperative visit (around 2 weeks post discharge) | 
| Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | Before discharge (approximately 24 hours after surgery) | 
| Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values | at time of postoperative visit (around 2 weeks post discharge) | 
| Incidence of postoperative renal injury using investigational renal biomarkers | MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml | Before discharge (approximately 24 hours after surgery) | 
| Incidence of postoperative renal injury using investigational renal biomarkers | MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml | at time of postoperative visit (around 2 weeks post discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | before discharge | 
| Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | at time of postoperative visit (around 2 weeks post discharge) | 
| Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | before discharge | 
| Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | at time of postoperative visit (around 2 weeks post discharge) | 
| Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | before discharge and at time of postoperative visit (around 2 weeks post discharge) | 
| Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | before discharge | 
| Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | at time of postoperative visit (around 2 weeks post discharge) | 
| Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | before discharge | 
| Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | at time of postoperative visit (around 2 weeks post discharge) | 
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | before discharge | 
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension | Pain score assessment using the visual analog score | at time of postoperative visit (around 2 weeks post discharge) | 
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | before discharge | 
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension | Pain medication consumption measured in mg | at time of postoperative visit (around 2 weeks post discharge) |