Cardiac and Renal Biomarkers in Arthroplasty Surgery

The Washington University

Status and phase: Terminated; Phase 4

Conditions: Arthropathy of Hip; Arthropathy of Knee; Myocardial Injury; Anesthesia; Renal Injury

Treatments: Drug: General Anesthetics; Drug: Spinal Anesthesia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03940651

201812100

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Knee Arthroplasty

Experimental group

Description:

Surgery to replace the knee joint with prothetic joint

Treatment:

Drug: Spinal Anesthesia

Drug: General Anesthetics

Hip Arthroplasty

Experimental group

Description:

Surgery to replace the hip joint with prothetic joint

Treatment:

Drug: Spinal Anesthesia

Drug: General Anesthetics