Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery
NCT ID: NCT03630796
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
66 participants
INTERVENTIONAL
2018-08-20
2019-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Sevoflurane
Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
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.
TIVA
Total intravenous anesthesia
Interventions
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Sevoflurane
Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
TIVA
Total intravenous anesthesia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
24 Months
ALL
No
Sponsors
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Instituto do Coracao
OTHER_GOV
Responsible Party
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Filomena R B G Galas
Phd MD
Locations
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Incor - Heart Institute - University of Sao Paulo
São Paulo, , Brazil
Countries
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Facility Contacts
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Other Identifiers
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4343.19.009
Identifier Type: -
Identifier Source: org_study_id
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