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

Ketamine

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).

Intervention / Treatment

  • Sevoflurane (DRUG)
    Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
  • TIVA (DRUG)
    Total intravenous anesthesia

Condition or Disease

  • Congenital Heart Defects

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: up to 24 Months   (Child)
    Enrollment: 66 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Aug 20, 2018 ACTUAL
    Primary Completion: Dec 01, 2019 ESTIMATED
    Completion Date: Dec 01, 2019 ESTIMATED
    Study First Posted: Aug 15, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 03, 2018

    Sponsors / Collaborators

    Lead Sponsor: Instituto do Coracao
    Responsible Party: N/A

    Location

    Sao Paulo, Brazil

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Maximum Age: 2
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    • Dosage of serum troponin I during the first 72 hours after surgery

    Secondary Outcomes

    • Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery

    • According to pediatric RIFLE

    • Arrhythmia, low cardiac output syndrome

    • 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

    More Details

    NCT Number: NCT03630796
    Other IDs: 4343.19.009
    Study URL: https://clinicaltrials.gov/study/NCT03630796
    Last updated: Sep 29, 2023