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

Congenital Heart Defects Clinical Trial

Official title:

Effect of Sevoflurane Anesthesia in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03630796
• Other study ID #: 4343.19.009
• Status: Recruiting
• Phase: Phase 4
• Start date: August 20, 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

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

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels curve of troponin I	Dosage of serum troponin I during the first 72 hours after surgery	T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Secondary	Serum levels curve of CKMB, CPK and BNP	Dosage of serum CKMB, CPK and BNP during the first 72 hours after surgery	T0: induction anesthesia; T1: ICU admission; T2: 24 hours after surgery; T3: 48 hours after surgery; T4: 72 hours after surgery
Secondary	Acute kidney injury	According to pediatric RIFLE	within 30 days after cardiac surgery
Secondary	Cardiac complications	Arrhythmia, low cardiac output syndrome	within 30 days after cardiac surgery
Secondary	Blood transfusion		within 30 days after cardiac surgery
Secondary	Length of vasoactive drugs		within 30 days after cardiac surgery
Secondary	Duration of Mechanical ventilation		within 30 days after cardiac surgery
Secondary	Length of ICU stay		within 30 days after cardiac surgery
Secondary	Length of hospital stay		within 30 days after cardiac surgery