Cardiac and Renal Biomarkers in Arthroplasty Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03940651
• Other study ID #: 201812100
• Status: Terminated
• Phase: Phase 4
• Start date: September 4, 2019
• Est. completion date: September 23, 2020

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases
• Myocardial Injury
• Renal Injury
• Wounds and Injuries

Intervention

Drug:
• Spinal Anesthesia
Patients will be randomized to type of anesthesia
• General Anesthetics
Patients will be randomized to type of anesthesia

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Abbott, BioMérieux

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Before discharge (approximately 24 hours after surgery)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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
Secondary	Difference renal biomarkers levels according to anesthesia 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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)