The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
- Registration Number
- NCT01450956
- Lead Sponsor
- Xijing Hospital
- Brief Summary
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- pediatric patients (body weight < 10 kg)
- diagnosed with congenital heart diseases
- scheduled for repair operation with CPB
- in the Department of Cardiovascular Surgery, Xijing Hospital
- systemic infections
- other systemic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Patients will receive only oxygen and air through oxygenator Sevoflurane Sevoflurane Patients will receive 2% sevoflurane via oxygenator during CPB
- Primary Outcome Measures
Name Time Method all cause mortality within the first 30 days (plus or minus 3 days) after surgery All cause mortality after the cardaic surgery, patients will be followed up for 30 days
- Secondary Outcome Measures
Name Time Method serum cTnI concentrations 48 h after the surgery serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.
Trial Locations
- Locations (1)
Department of Cardiovascular Surgery, Xijing Hospital
🇨🇳Xi'an, Shaanxi, China