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

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Metabolic Acidosis

Study type

Observational

Funder types

Other

Identifiers

NCT01295190
Fudickar3

Details and patient eligibility

About

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.

Full description

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

Enrollment

200 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Children scheduled for heart surgery including cardiopulmonary bypass

Trial design

200 participants in 2 patient groups

Propofol
Description:
Patients receiving Propofol during cardiopulmonary bypass.
Sevoflurane
Description:
Patients receiving sevoflurane during cardiopulmonary bypass

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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