Congenital Heart DefectsPhase 4NCT03630796
Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery
A Phase 4 study testing Sevoflurane and TIVA in people with Congenital Heart Defects, run by Instituto do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Sevoflurane and TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2018to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Heart Institute - University of Sao Paulo
São Paulo, 05403000
Filomena RG Galas, +551126615232, filomenagalas@hotmail.com
About this study
Official title: Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial
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).
- Conditions
- Congenital Heart Defects
- Being tested
- Sevoflurane, TIVA
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
TIVADrug
Total intravenous anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | 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. Receives: Drug: Sevoflurane |
| Intravenous anesthetics (TIVA) | Other | 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. Receives: Drug: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels curve of troponin I
Dosage of serum troponin I during the first 72 hours after surgery
Measured: T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Secondary outcomes (8)
Serum levels curve of CKMB, CPK and BNP
Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery
Measured: T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Acute kidney injury
According to pediatric RIFLE
Measured: within 30 days after cardiac surgery
Cardiac complications
Arrhythmia, low cardiac output syndrome
Measured: within 30 days after cardiac surgery
Blood transfusion
Measured: within 30 days after cardiac surgery
Length of vasoactive drugs
Measured: within 30 days after cardiac surgery
Duration of Mechanical ventilation
Measured: within 30 days after cardiac surgery
Length of ICU stay
Measured: within 30 days after cardiac surgery
Length of hospital stay
Measured: within 30 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Aug 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Filomena R B G Galas, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630796
- Sponsor's protocol ID
- 4343.19.009
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03630796
- Acronym / sponsor ID
- 4343.19.009
- Conditions
- Congenital Heart Defects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneAnesthetic 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. |
| Intravenous anesthetics (TIVA) | Other | Drug: TIVAAnesthetic 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneUse of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries. | Drug | Sevoflurane |
| TIVATotal intravenous anesthesia | Drug | Intravenous anesthetics (TIVA) |
Primary outcome
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
8 secondary outcomes
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
Acute kidney injury
Time frame: within 30 days after cardiac surgery
Cardiac complications
Time frame: within 30 days after cardiac surgery
Blood transfusion
Time frame: within 30 days after cardiac surgery
Length of vasoactive drugs
Time frame: within 30 days after cardiac surgery
Duration of Mechanical ventilation
Time frame: within 30 days after cardiac surgery
Length of ICU stay
Time frame: within 30 days after cardiac surgery
Length of hospital stay
Time frame: within 30 days after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Related trials for Congenital Heart Defects
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and TIVA in people with Congenital Heart Defects, run by Instituto do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.