Cardiac and Renal Biomarkers in Arthroplasty Surgery

Phase 4TerminatedNCT03940651

Washington University School of Medicine1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Renal Injury Anesthesia Myocardial Injury Arthropathy of Knee Arthropathy of Hip

Interventions

Spinal AnesthesiaDRUG

Patients will be randomized to type of anesthesia

General AnestheticsDRUG

Patients will be randomized to type of anesthesia

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively

Hs-cTnI increase \>50% above the sex-specific 99th percentile upper reference limit

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Before discharge (approximately 24 hours after surgery)

Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population

Data from ClinicalTrials.gov

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Secondary Outcomes

Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension

Pain score assessment using the visual analog score

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: at time of postoperative visit (around 2 weeks post discharge)