Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01295190
Acronym
PRISKIKO
Enrollment
200
Registered
2011-02-14
Start date
2009-06-30
Completion date
2010-08-31
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Acidosis

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 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

Interventions

None listed

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

* Children scheduled for heart surgery including cardiopulmonary bypass

Design outcomes

Primary

MeasureTime frameDescription
Metabolic acidosis during cardiopulmonary bypass2 hoursChanges of pH, base excess and lactate relative to baseline are analysed.

Secondary

MeasureTime frameDescription
Outcome parameter1 monthDuration of intensive care treatment and time to dismission from hospital are compared between groups.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026