Clinical Trials Directory

Trials / Terminated

TerminatedNCT03940651

Cardiac and Renal Biomarkers in Arthroplasty Surgery

Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGSpinal AnesthesiaPatients will be randomized to type of anesthesia
DRUGGeneral AnestheticsPatients will be randomized to type of anesthesia

Timeline

Start date
2019-09-04
Primary completion
2020-09-23
Completion
2020-09-23
First posted
2019-05-07
Last updated
2021-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03940651. Inclusion in this directory is not an endorsement.