Clinical Trials Directory

Trials / Completed

CompletedNCT01295190

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
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
University Hospital Schleswig-Holstein · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2009-06-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2011-02-14
Last updated
2014-05-22

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01295190. Inclusion in this directory is not an endorsement.