Clinical trial NCT03630796: Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery
Official title: Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congenital Heart Defects
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2018-08-15
Enrollment: 66
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Serum levels curve of troponin I
timeFrame: T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Secondary outcomes:
measure: Serum levels curve of CKMB, CPK and BNP
timeFrame: T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
measure: Acute kidney injury
timeFrame: within 30 days after cardiac surgery
measure: Cardiac complications
timeFrame: within 30 days after cardiac surgery
measure: Blood transfusion
timeFrame: within 30 days after cardiac surgery
measure: Length of vasoactive drugs
timeFrame: within 30 days after cardiac surgery
measure: Duration of Mechanical ventilation
timeFrame: within 30 days after cardiac surgery
measure: Length of ICU stay
timeFrame: within 30 days after cardiac surgery
measure: Length of hospital stay
timeFrame: within 30 days after cardiac surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
References: