Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery
- Registration Number
- NCT03630796
- Lead Sponsor
- Instituto do Coracao
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous anesthetics (TIVA) 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. Sevoflurane 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.
- Primary Outcome Measures
Name Time Method Serum levels curve of troponin I 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
- Secondary Outcome Measures
Name Time Method Blood transfusion within 30 days after cardiac surgery Acute kidney injury within 30 days after cardiac surgery According to pediatric RIFLE
Duration of Mechanical ventilation within 30 days after cardiac surgery Length of hospital stay 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 Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery
Cardiac complications within 30 days after cardiac surgery Arrhythmia, low cardiac output syndrome
Length of vasoactive drugs within 30 days after cardiac surgery Length of ICU stay within 30 days after cardiac surgery
Trial Locations
- Locations (1)
Incor - Heart Institute - University of Sao Paulo
🇧🇷Sao Paulo, Brazil