Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass (PRISKIKO)
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.
|Official Title:||Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome|
- Metabolic acidosis during cardiopulmonary bypass [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Changes of pH, base excess and lactate relative to baseline are analysed.
- Outcome parameter [ Time Frame: 1 month ] [ Designated as safety issue: No ]Duration of intensive care treatment and time to dismission from hospital are compared between groups.
|Study Start Date:||June 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Patients receiving Propofol during cardiopulmonary bypass.
Patients receiving sevoflurane during cardiopulmonary bypass
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295190
|University Hospital Schleswig-Holstein|
|Kiel, Schleswig-Holstein, Germany, 24105|
|Principal Investigator:||Axel Fudickar, Dr.||University of Schleswig-Holstein|