Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
研究概览
简要总结
The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.
排除标准
- •Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease
研究组 & 干预措施
Ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
干预措施: ropivacaine (Drug)
saline
caudal block with 1 ml/kg of saline
干预措施: saline (Drug)
结局指标
主要结局
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
时间窗: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery
时间窗: baseline(before induction of anesthesia), 3h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery
时间窗: baseline(before induction of anesthesia), 24h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery
时间窗: baseline(before induction of anesthesia), 24h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery
时间窗: baseline(before induction of anesthesia), 72h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery
时间窗: baseline(before induction of anesthesia), 48h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery
时间窗: baseline(before induction of anesthesia), 72h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery
时间窗: baseline(before induction of anesthesia), 24h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery
时间窗: baseline(before induction of anesthesia), 48h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery
时间窗: baseline(before induction of anesthesia), 3h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery
时间窗: baseline(before induction of anesthesia), 3h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery
时间窗: baseline(before induction of anesthesia), 48h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery
时间窗: baseline(before induction of anesthesia), 72h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery
时间窗: baseline(before induction of anesthesia), 72h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery
时间窗: baseline(before induction of anesthesia), 48h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery
时间窗: baseline(before induction of anesthesia), 24h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery
时间窗: baseline(before induction of anesthesia), 48h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit
时间窗: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit
时间窗: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit
时间窗: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery
时间窗: baseline(before induction of anesthesia), 3h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery
时间窗: baseline(before induction of anesthesia), 72h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery
时间窗: baseline(before induction of anesthesia), 3h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery
时间窗: baseline(before induction of anesthesia), 24h after surgery
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit
时间窗: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
次要结局
- change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit(baseline(just before the start of surgery), at arrival in the postanesthesia care unit)
- change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery(baseline(just before the start of surgery), 3h after surgery)
- change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit(baseline(just before the start of surgery), at arrival in the postanesthesia care unit)
- change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery(baseline(just before the start of surgery), 3h after surgery)
- change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit(baseline(just before the start of surgery), at arrival in the postanesthesia care unit)
- change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery(baseline(just before the start of surgery), 3h after surgery)
研究者
Si-Qin Chen
attending doctor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine