Congenital Heart Defects
Conditions
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).
Interventions
DRUGSevoflurane
Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
DRUGTIVA
Total intravenous anesthesia
Sponsors
Instituto do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | within 30 days after cardiac surgery | According to pediatric RIFLE |
| Cardiac complications | within 30 days after cardiac surgery | Arrhythmia, low cardiac output syndrome |
| Blood transfusion | 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 |
| 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 | — |
| Length of vasoactive drugs | within 30 days after cardiac surgery | — |
Countries
Brazil
Outcome results
None listed