NCT03630796

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Instituto do Coracao · Other Government
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Congenital Heart Defects

Interventions

Type	Name	Description
DRUG	Sevoflurane	Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
DRUG	TIVA	Total intravenous anesthesia

Timeline

• Start date: 2018-08-20
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-08-15
• Last updated: 2018-09-05

Locations

1 site across 1 country: Brazil