Clinical trial NCT03940651: Cardiac and Renal Biomarkers in Arthroplasty Surgery
Official title: Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Injury
Anesthesia
Myocardial Injury
Arthropathy of Knee
Arthropathy of Hip
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Abbott
name: BioMérieux
First posted: 2019-05-07
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
timeFrame: Before discharge (approximately 24 hours after surgery)
measure: Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population
timeFrame: Before discharge (approximately 24 hours after surgery)
measure: Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population
timeFrame: Before discharge (approximately 24 hours after surgery)
measure: Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
timeFrame: Before discharge (approximately 24 hours after surgery)
measure: Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Incidence of postoperative renal injury using investigational renal biomarkers
timeFrame: Before discharge (approximately 24 hours after surgery)
measure: Incidence of postoperative renal injury using investigational renal biomarkers
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
Secondary outcomes:
measure: Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension
timeFrame: before discharge and at time of postoperative visit (around 2 weeks post discharge)
measure: Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
measure: The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: before discharge
measure: The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension
timeFrame: at time of postoperative visit (around 2 weeks post discharge)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mohammad Helwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.