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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03940651
Other study ID # 201812100
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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)
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