Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial

Conditions
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Congenital Heart Defects

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: TIVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Written informed consent (signed by the parents) Scheduled Congenital Heart Defect Repair Surgery RACHS Risk Score 1, 2 or 3. On-pump Surgery Age: 2 years old (completed) or younger Patients without previous kidney disease or any contraindication for inhaled anesthesia (including previous unusual response to an anesthetic agent) No previous general anesthesia in the last 30 days. Exclusion Criteria Emergency surgery Off-pump surgery (surgery plan changed by the surgeon after patient's randomization) Refuse to take part of the study or ask to leave the trial

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>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. | Drug: Sevoflurane<br>* Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.<br>|
| Other: Intravenous anesthetics (TIVA)<br>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. | Drug: TIVA<br>* Total intravenous anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels curve of troponin I | Dosage of serum troponin I during the first 72 hours after surgery | T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels curve of CKMB, CPK and BNP | Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery | T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery | 
| Acute kidney injury | According to pediatric RIFLE | within 30 days after cardiac surgery | 
| Cardiac complications | Arrhythmia, low cardiac output syndrome | within 30 days after cardiac surgery | 
| Blood transfusion |  | within 30 days after cardiac surgery | 
| Length of vasoactive drugs |  | within 30 days after cardiac surgery | 
| Duration of Mechanical ventilation |  | within 30 days after cardiac surgery | 
| Length of ICU stay |  | within 30 days after cardiac surgery | 
| Length of hospital stay |  | within 30 days after cardiac surgery |