The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Congenital Heart Diseases

Treatments: Other: Control; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01450956

XJXZ2011-010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• systemic infections
• other systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Sevoflurane

Experimental group

Description:

Patients will receive 2% sevoflurane via oxygenator during CPB

Treatment:

Drug: Sevoflurane

Control

No Intervention group

Description:

Patients will receive only oxygen and air through oxygenator

Treatment:

Other: Control