Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Serum levels curve of troponin I
研究概览
简要总结
The main purpose of this study is to compare myocardial injury of patients undergoing congenital cardiac defects repair surgery (RACHS Risk Score one, two or three) under total intravenous anesthesia compared to inhalation anesthesia with sevoflurane. The primary aim of the study is to evaluate the troponin I levels in patients following congenital heart surgery and elucidate if one of the two anesthetic techniques (TIVA x inhalation anesthesia) is more effective in reducing troponin I levels in the first 72h after surgery..
Sixty six are planned to be included in the study and the follow-up will take approximately 3 days for the primary outcome.
As a secondary outcome evaluate the BNP, CPK and CKMB postoperative levels in the same period (72h), also ICU and hospital lengh of stay (LOS), duration of mechanical ventilation, inotropic/vasoactive drugs use and incidence of renal injury (according to pediatric RIFLE score).
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 (Participant)
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sevoflurane
Anesthetic induction with sevoflurane by mask 3-8% and fresh gas flow 2-8 l/min (FiO2 50-100%) followed by ketamine 1-2 mg/kg, midazolam 0,1-0,5 mg/kg, fentanyl 2-4 mcg/kg and pancuronium 0,1 mg/kg.
After orotracheal intubation, anesthesia is maintained with fentanyl 10 - 30 mcg/kg according to clinical needs and sevoflurane 1-3% (end-tidal concentration) before and after cardiopulmonary bypass. Specifically during cardiopulmonary bypass extra fentanyl 1-5 mcg/kg and pancuronium 0,1 mg/kg will be administered and the sevoflurane sustained 1-3% in a specific sevoflurane vaporizer included in the CPB machine.
Pressure-controlled ventilation will be applied to both groups objectifying normocarbia and normoxia.
Ringer's lactate (RL) will be used as crystalloid solution for fluid therapy.
干预措施: Sevoflurane (Drug)
Intravenous anesthetics (TIVA)
Anesthetic induction with ketamine 1-3 mg/kg, midazolam 0,1-0,5 mg/kg, fentanyl 2-4 mcg/kg and pancuronium 0,1 mg/kg after preoxygenation with FiO2 between 50-100% and fresh gas flow 4-8 l/min.
After orotracheal intubation, anesthesia is maintained with fentanyl 10 - 30 mcg/kg according to clinical needs and continuous infusion of midazolam and ketamine 0,2-0,8 mg/kg/h and 1-2 mg/kg/h respectively before and after cardiopulmonary bypass. Specifically during cardiopulmonary bypass extra fentanyl 1-5 mcg/kg, midazolam 0,1-0,5 mg/kg and pancuronium 0,1 mg/kg will be administered.
Pressure-controlled ventilation will be applied to both groups objectifying normocarbia and normoxia.
Ringer's lactate (RL) will be used as crystalloid solution for fluid therapy.
干预措施: TIVA (Drug)
结局指标
主要结局
Serum levels curve of troponin I
时间窗: T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Dosage of serum troponin I during the first 72 hours after surgery
次要结局
- Acute kidney injury(within 30 days after cardiac surgery)
- Serum levels curve of CKMB, CPK and BNP(T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery)
- Cardiac complications(within 30 days after cardiac surgery)
- Length of vasoactive drugs(within 30 days after cardiac surgery)
- Blood transfusion(within 30 days after cardiac surgery)
- Duration of Mechanical ventilation(within 30 days after cardiac surgery)
- Length of hospital stay(within 30 days after cardiac surgery)
- Length of ICU stay(within 30 days after cardiac surgery)
研究者
Filomena R B G Galas
Phd MD
Instituto do Coracao