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

Primary Purpose

Congenital Heart Defects

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Sevoflurane
TIVA
Sponsored by
Instituto do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Incor - Heart Institute - University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Sevoflurane

Intravenous anesthetics (TIVA)

Arm Description

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.

Outcomes

Primary Outcome Measures

Serum levels curve of troponin I
Dosage of serum troponin I during the first 72 hours after surgery

Secondary Outcome Measures

Serum levels curve of CKMB, CPK and BNP
Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery
Acute kidney injury
According to pediatric RIFLE
Cardiac complications
Arrhythmia, low cardiac output syndrome
Blood transfusion
Length of vasoactive drugs
Duration of Mechanical ventilation
Length of ICU stay
Length of hospital stay

Full Information

First Posted
August 10, 2018
Last Updated
September 3, 2018
Sponsor
Instituto do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT03630796
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Coracao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intravenous anesthetics (TIVA)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
Intervention Type
Drug
Intervention Name(s)
TIVA
Intervention Description
Total intravenous anesthesia
Primary Outcome Measure Information:
Title
Serum levels curve of troponin I
Description
Dosage of serum troponin I during the first 72 hours after surgery
Time Frame
T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Secondary Outcome Measure Information:
Title
Serum levels curve of CKMB, CPK and BNP
Description
Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery
Time Frame
T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Title
Acute kidney injury
Description
According to pediatric RIFLE
Time Frame
within 30 days after cardiac surgery
Title
Cardiac complications
Description
Arrhythmia, low cardiac output syndrome
Time Frame
within 30 days after cardiac surgery
Title
Blood transfusion
Time Frame
within 30 days after cardiac surgery
Title
Length of vasoactive drugs
Time Frame
within 30 days after cardiac surgery
Title
Duration of Mechanical ventilation
Time Frame
within 30 days after cardiac surgery
Title
Length of ICU stay
Time Frame
within 30 days after cardiac surgery
Title
Length of hospital stay
Time Frame
within 30 days after cardiac surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Incor - Heart Institute - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filomena RG Galas
Phone
+551126615232
Email
filomenagalas@hotmail.com

12. IPD Sharing Statement

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

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