Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630796
Recruitment Status : Unknown
Verified September 2018 by Filomena R B G Galas, Instituto do Coracao.
Recruitment status was:  Recruiting
First Posted : August 15, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Filomena R B G Galas, Instituto do Coracao

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Congenital Heart Defects Drug: Sevoflurane Drug: TIVA Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 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.

 Drug: 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.

 Drug: TIVA
Total intravenous anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Serum levels curve of troponin I [ Time Frame: 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 Outcome Measures :
  1. Serum levels curve of CKMB, CPK and BNP [ Time Frame: 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

  2. Acute kidney injury [ Time Frame: within 30 days after cardiac surgery ]
    According to pediatric RIFLE

  3. Cardiac complications [ Time Frame: within 30 days after cardiac surgery ]
    Arrhythmia, low cardiac output syndrome

  4. Blood transfusion [ Time Frame: within 30 days after cardiac surgery ]
  5. Length of vasoactive drugs [ Time Frame: within 30 days after cardiac surgery ]
  6. Duration of Mechanical ventilation [ Time Frame: within 30 days after cardiac surgery ]
  7. Length of ICU stay [ Time Frame: within 30 days after cardiac surgery ]
  8. Length of hospital stay [ Time Frame: within 30 days after cardiac surgery ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630796


Locations
Layout table for location information
Brazil
Incor - Heart Institute - University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403000
Contact: Filomena RG Galas    +551126615232    filomenagalas@hotmail.com   
Sponsors and Collaborators
Instituto do Coracao
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Filomena R B G Galas, Phd MD, Instituto do Coracao
ClinicalTrials.gov Identifier: NCT03630796    
Other Study ID Numbers: 4343.19.009
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sevoflurane
 Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs