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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Coracao
• Treatments: Anesthetics; Sevoflurane

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