Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children scheduled for heart surgery including cardiopulmonary bypass

Treatment and study plan

Primary outcomes

Metabolic acidosis during cardiopulmonary bypass

Time frame: 2 hours

Changes of pH, base excess and lactate relative to baseline are analysed.

Secondary outcomes

Outcome parameter

Time frame: 1 month

Duration of intensive care treatment and time to dismission from hospital are compared between groups.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Acronym: PRISKIKO

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 14, 2011
Registry last updated: May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed