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Funding ended
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| BioMérieux | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Arthroplasty | Experimental | Surgery to replace the knee joint with prothetic joint |
|
| Hip Arthroplasty | Experimental | Surgery to replace the hip joint with prothetic joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia | Drug | Patients will be randomized to type of anesthesia |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Helwani, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. | |
| 23011713 | Background | Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36. doi: 10.1001/2012.jama.11153. |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000777 | Anesthetics |
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| General Anesthetics | Drug | Patients will be randomized to type of anesthesia |
|
| 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) |
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) |
| 25029449 | Background | Khan J, Alonso-Coello P, Devereaux PJ. Myocardial injury after noncardiac surgery. Curr Opin Cardiol. 2014 Jul;29(4):307-11. doi: 10.1097/HCO.0000000000000069. |
| D002492 |
| Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |