Clinical Trial: Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

Brief Summary: Propofol has been routinely used for general anesthesia during pediatric cardiopulmonary bypass at our institution without complications. However, propofol may cause propofol infusion syndrome (PRIS), a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia. Metabolic acidosis is regarded as an early warning sign of PRIS. Due to the preconditioning effects of sevoflurane and its availability for cardiopulmonary bypass, propofol has recently been substituted by sevoflurane during pediatric cardiopulmonary bypass at our institution. In this study the effect of substituting propofol by sevoflurane on metabolic acidosis and outcome are examined.

Detailed Summary: In this retrospective and partially prospective observational study the charts of 200 children anesthetised for pediatric heart surgery are analysed since September 2007. 100 children received propofol and up to now 80 children received sevoflurane during cardiopulmonary bypass. Blood gas analysis, laboratory results and vital parameters are compared before and after cardiopulmonary bypass for each group. Duration of intensive care treatment and time to dismission from hospital are compared between groups. Changes relative to baseline are analysed by paired t-Test with correction for multiple testing. Differences between groups are analysed by unpaired t-Test with correction for multiple testing
Sponsor: University of Schleswig-Holstein

Current Primary Outcome: Metabolic acidosis during cardiopulmonary bypass [ Time Frame: 2 hours ]

Changes of pH, base excess and lactate relative to baseline are analysed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Outcome parameter [ Time Frame: 1 month ]

Duration of intensive care treatment and time to dismission from hospital are compared between groups.


Original Secondary Outcome: Same as current

Information By: University of Schleswig-Holstein

Dates:
Date Received: February 11, 2011
Date Started: June 2009
Date Completion:
Last Updated: May 21, 2014
Last Verified: May 2014