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

Sponsor

Instituto do Coracao (Other)

Overall Status

Unknown status

CT.gov ID

NCT03630796

Collaborator

(none)

Enrollment

Location

Arms

15.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defects	Drug: Sevoflurane Drug: TIVA	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 20, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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.
Other: 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

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.

Other: 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

Primary Outcome Measures

Serum levels curve of troponin I [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

Serum levels curve of CKMB, CPK and BNP [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
Acute kidney injury [within 30 days after cardiac surgery]
According to pediatric RIFLE
Cardiac complications [within 30 days after cardiac surgery]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 24 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Incor - Heart Institute - University of Sao Paulo	Sao Paulo		Brazil	05403000

Sponsors and Collaborators

Instituto do Coracao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Aug 15, 2018

Last Update Posted:

Sep 5, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Defects, Congenital

Sevoflurane

Study Results

No Results Posted as of Sep 5, 2018