Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass (PRISKIKO)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Metabolic Acidosis |
| Study Type: | Observational |
| Official Title: | Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass: Effect on Metabolic Acidosis and Clinical Outcome |
- Metabolic acidosis during cardiopulmonary bypass [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Changes of pH, base excess and lactate relative to baseline are analysed.
- Outcome parameter [ Time Frame: 1 month ] [ Designated as safety issue: No ]Duration of intensive care treatment and time to dismission from hospital are compared between groups.
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2009 |
| Groups/Cohorts |
|---|
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Propofol
Patients receiving Propofol during cardiopulmonary bypass.
|
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Sevoflurane
Patients receiving sevoflurane during cardiopulmonary bypass
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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
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children scheduled for heart surgery including cardiopulmonary bypass.
Inclusion Criteria:
- Children scheduled for heart surgery including cardiopulmonary bypass
Contacts and Locations| Contact: Axel Fudickar, Dr. | 0049(0)4315972991 | fudickar@anaesthesie.uni-kiel.de |
| Germany | |
| University Hospital Schleswig-Holstein | Recruiting |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Contact: Axel Fudickar, Dr. 0049(0)4315972991 fudickar@anaesthesie.uni-kiel.de | |
| Principal Investigator: | Axel Fudickar, Dr. | University of Schleswig-Holstein |
More Information
No publications provided
| Responsible Party: | Axel Fudickar, University Hospital Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT01295190 History of Changes |
| Other Study ID Numbers: | Fudickar3 |
| Study First Received: | February 11, 2011 |
| Last Updated: | February 11, 2011 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Acidosis Acid-Base Imbalance Metabolic Diseases Propofol Sevoflurane Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on May 16, 2013