Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass

Metabolic Acidosis Clinical Trial

— PRISKIKO  

Official title:

Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295190
• Other study ID #: Fudickar3
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: May 21, 2014
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Children scheduled for heart surgery including cardiopulmonary bypass

Study Design

N/A

Related Conditions & MeSH terms

• Acidosis
• Metabolic Acidosis

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic acidosis during cardiopulmonary bypass	Changes of pH, base excess and lactate relative to baseline are analysed.	2 hours	No
Secondary	Outcome parameter	Duration of intensive care treatment and time to dismission from hospital are compared between groups.	1 month	No