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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Acidosis

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • University Hospital Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children scheduled for heart surgery including cardiopulmonary bypass.

Description

Inclusion Criteria:

• Children scheduled for heart surgery including cardiopulmonary bypass

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Propofol; Patients receiving Propofol during cardiopulmonary bypass.
Sevoflurane; Patients receiving sevoflurane during cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic acidosis during cardiopulmonary bypass	Changes of pH, base excess and lactate relative to baseline are analysed.	2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Axel Fudickar, Dr., University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: Fudickar3