Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass

Completed

• Conditions: Metabolic Acidosis

• Registration Number: NCT01295190
• Lead Sponsor: University Hospital Schleswig-Holstein

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

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children scheduled for heart surgery including cardiopulmonary bypass

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic acidosis during cardiopulmonary bypass	2 hours	Changes of pH, base excess and lactate relative to baseline are analysed.

Secondary Outcome Measures

Name	Time	Method
Outcome parameter	1 month	Duration of intensive care treatment and time to dismission from hospital are compared between groups.

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany