Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 8:56 AM
Study NCT ID:
NCT01293266
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-10', 'studyFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Lactate', 'timeFrame': '4 hours', 'description': 'Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.'}], 'secondaryOutcomes': [{'measure': 'pH and base excess', 'timeFrame': 'Hours', 'description': 'pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Propofol', 'Metabolic Acidosis', 'Pediatric Cardiology', 'Anesthesia'], 'conditions': ['Metabolic Acidosis']}, 'descriptionModule': {'briefSummary': 'Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.', 'detailedDescription': 'In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for heart catheterization under general anesthesia\n\nExclusion Criteria:\n\n* Participation in another study\n* Preexisting metabolic acidosis\n* Contraindication against Propofol'}, 'identificationModule': {'nctId': 'NCT01293266', 'acronym': 'PRISCATHLAB', 'briefTitle': 'Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation', 'orgStudyIdInfo': {'id': 'Fudickar2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.', 'interventionNames': ['Drug: Propofol']}, {'type': 'NO_INTERVENTION', 'label': 'Sevoflurane', 'description': 'Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.'}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Disoprivan'], 'description': 'Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Berthold Bein, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Anaesthesiology and Intensive Care Medicine', 'oldOrganization': 'University Hospital Schleswig-Holstein, Campus Kiel'}}}}