Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Unbound Cefazolin Concentration in Skeletal Muscle
研究概览
简要总结
The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.
详细描述
Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic scoliosis
- •Planned posterior spinal fusion surgery (PSFS)
- •Age: 12-20 years old
- •American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
- •No known allergy to cefazolin
排除标准
- •Known allergy to cefazolin
- •Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
- •Known renal or hepatic insufficiency or failure
研究组 & 干预措施
First Regimen Group
The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.
干预措施: Bolus dose of Cefazolin (Drug)
First Regimen Group
The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.
干预措施: Paraspinal muscle microdialysis catheters (Device)
First Regimen Group
The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.
干预措施: Subcutaneous microdialysis catheters (Device)
Second Regimen Group
The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.
干预措施: Continuous Cefazolin drip (Drug)
Second Regimen Group
The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.
干预措施: Paraspinal muscle microdialysis catheters (Device)
Second Regimen Group
The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.
干预措施: Subcutaneous microdialysis catheters (Device)
结局指标
主要结局
Unbound Cefazolin Concentration in Skeletal Muscle
时间窗: Changes from baseline (pre-op) up to end of surgical procedure
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Unbound Cefazolin in Adipose Tissue
时间窗: Changes from baseline (pre-op) up to end of surgical procedure
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue
次要结局
未报告次要终点