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Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass (PRISKIKO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01295190
First received: February 11, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 11, 2011
February 11, 2011
June 2009
Not Provided
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass
Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

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.

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
Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

Children scheduled for heart surgery including cardiopulmonary bypass.
Metabolic Acidosis
Not Provided
  • Propofol
    Patients receiving Propofol during cardiopulmonary bypass.
  • Sevoflurane
    Patients receiving sevoflurane during cardiopulmonary bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

Inclusion Criteria:

  • Children scheduled for heart surgery including cardiopulmonary bypass
Both
up to 16 Years
No
Contact: Axel Fudickar, Dr. 0049(0)4315972991 fudickar@anaesthesie.uni-kiel.de
Germany
 
NCT01295190
Fudickar3
No
Axel Fudickar, University Hospital Schleswig-Holstein
University of Schleswig-Holstein
Not Provided
Principal Investigator: Axel Fudickar, Dr. University of Schleswig-Holstein
University of Schleswig-Holstein
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP