Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age 60 years or older
- •Ability to provide informed consent
- •American Society of Anesthesiologists (ASA) classification II or higher
排除标准
- •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
研究组 & 干预措施
Knee Arthroplasty
Surgery to replace the knee joint with prothetic joint
干预措施: Spinal Anesthesia (Drug)
Knee Arthroplasty
Surgery to replace the knee joint with prothetic joint
干预措施: General Anesthetics (Drug)
Hip Arthroplasty
Surgery to replace the hip joint with prothetic joint
干预措施: Spinal Anesthesia (Drug)
Hip Arthroplasty
Surgery to replace the hip joint with prothetic joint
干预措施: General Anesthetics (Drug)
结局指标
主要结局
Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population
时间窗: at time of postoperative visit (around 2 weeks post discharge)
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively
时间窗: at time of postoperative visit (around 2 weeks post discharge)
Hs-cTnI increase \>50% above the sex-specific 99th percentile upper reference limit
Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population
时间窗: at time of postoperative visit (around 2 weeks post discharge)
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Incidence of postoperative renal injury using investigational renal biomarkers
时间窗: at time of postoperative visit (around 2 weeks post discharge)
MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml
Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population
时间窗: at time of postoperative visit (around 2 weeks post discharge)
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population
时间窗: at time of postoperative visit (around 2 weeks post discharge)
cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values
次要结局
- Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension(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(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(before discharge)
- The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension(at time of postoperative visit (around 2 weeks post discharge))
- Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension(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(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(at time of postoperative visit (around 2 weeks post discharge))