Renal Injury, Anesthesia, Myocardial Injury, Arthropathy of Knee, Arthropathy of Hip
Conditions
Brief summary
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
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
Interventions
DRUGSpinal Anesthesia
Patients will be randomized to type of anesthesia
Patients will be randomized to type of anesthesia
Sponsors
Abbott
BioMérieux
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively | Before discharge (approximately 24 hours after surgery) | Hs-cTnI increase \>50% above the sex-specific 99th percentile upper reference limit |
| Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population | Before discharge (approximately 24 hours after surgery) | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values |
| Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population | at time of postoperative visit (around 2 weeks post discharge) | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values |
| Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population | Before discharge (approximately 24 hours after surgery) | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values |
| Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population | Before discharge (approximately 24 hours after surgery) | cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values |
| Incidence of postoperative renal injury using investigational renal biomarkers | Before discharge (approximately 24 hours after surgery) | MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension | before discharge | Pain score assessment using the visual analog score |
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension | before discharge | Pain medication consumption measured in mg |
| Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension | before discharge | Pain medication consumption measured in mg |
| Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension | before discharge and at time of postoperative visit (around 2 weeks post discharge) | Pain score assessment using the visual analog score |
| Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension | at time of postoperative visit (around 2 weeks post discharge) | Pain score assessment using the visual analog score |
| Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension | before discharge | Pain medication consumption measured in mg |
| The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension | before discharge | Pain score assessment using the visual analog score |
Countries
United States
Outcome results
None listed