{ "FullStudy":{ "Rank":217610, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519154", "OrgStudyIdInfo":{ "OrgStudyId":"KEK-ZH Nr. 2011-0190" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011DR3171", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Swissmedic Referenznummer" } ] }, "Organization":{ "OrgFullName":"University Children's Hospital, Zurich", "OrgClass":"OTHER" }, "BriefTitle":"Sedation MRI - Propofol Versus Propofol-Ketamin in Children", "OfficialTitle":"Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)" }, "StatusModule":{ "StatusVerifiedDate":"November 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 26, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 2, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Achim Schmitz", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"University Children's Hospital, Zurich" }, "LeadSponsor":{ "LeadSponsorName":"Achim Schmitz", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Children < 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are\n\npropofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h\npropofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h\n\nboth protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow.\n\nHypothesis:\n\nreduces recovery time compared to propofol mono sedation\ncombination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation\ncombination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sedation" ] }, "KeywordList":{ "Keyword":[ "deep sedation", "propofol", "ketamine", "child", "preschool child", "infant", "recovery and quality of sedation" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"347", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Propofol", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Propofol 10 mg/h as maintenance infusion", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Propofol" ] } },{ "ArmGroupLabel":"Ketamine-Propofol", "ArmGroupType":"Experimental", "ArmGroupDescription":"Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Ketamine-Propofol" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Propofol", "InterventionDescription":"Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Propofol" ] } },{ "InterventionType":"Drug", "InterventionName":"Ketamine-Propofol", "InterventionDescription":"Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ketamine-Propofol" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Recovery time", "PrimaryOutcomeDescription":"Time from end of MRI until recovery defined as Aldrete Score = 10", "PrimaryOutcomeTimeFrame":"1 - 3 hours post anaesthesia" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Demission time", "SecondaryOutcomeDescription":"time until demission", "SecondaryOutcomeTimeFrame":"1 - 4 hours post anaesthesia" },{ "SecondaryOutcomeMeasure":"PONV", "SecondaryOutcomeDescription":"Postoperative nausea or vomiting", "SecondaryOutcomeTimeFrame":"24 hours" },{ "SecondaryOutcomeMeasure":"Cerebral perfusion", "SecondaryOutcomeDescription":"noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI", "SecondaryOutcomeTimeFrame":"first 10 minutes of MRI" },{ "SecondaryOutcomeMeasure":"Incidence of emergence delirium", "SecondaryOutcomeTimeFrame":"1 - 4 hours post anaesthesia" },{ "SecondaryOutcomeMeasure":"Quality of sedation", "SecondaryOutcomeDescription":"Extra Propofol doses and total amount of Propofol required, movement artefacts", "SecondaryOutcomeTimeFrame":"during MRI, on the average 45 minutes" },{ "SecondaryOutcomeMeasure":"respiratory and cardiovascular adverse events", "SecondaryOutcomeTimeFrame":"during sedation, on the average 60 minutes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMRT in deep sedation\noutpatient\n> 3 months to <= 10 years\n\nExclusion Criteria:\n\ntracheal intubation required\ncontraindication of ketamine or propofol\nadditional painful procedure requiring analgesics", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"3 Months", "MaximumAge":"10 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Achim J Schmitz, MD", "OverallOfficialAffiliation":"University Children's Hospital, Zurich", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University Children's Hospital Zurich", "LocationCity":"Zurich", "LocationZip":"8032", "LocationCountry":"Switzerland" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007649", "InterventionMeshTerm":"Ketamine" },{ "InterventionMeshId":"D000015742", "InterventionMeshTerm":"Propofol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000006993", "InterventionAncestorTerm":"Hypnotics and Sedatives" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018686", "InterventionAncestorTerm":"Anesthetics, Intravenous" },{ "InterventionAncestorId":"D000018681", "InterventionAncestorTerm":"Anesthetics, General" },{ "InterventionAncestorId":"D000000777", "InterventionAncestorTerm":"Anesthetics" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000000778", "InterventionAncestorTerm":"Anesthetics, Dissociative" },{ "InterventionAncestorId":"D000018691", "InterventionAncestorTerm":"Excitatory Amino Acid Antagonists" },{ "InterventionAncestorId":"D000018683", "InterventionAncestorTerm":"Excitatory Amino Acid Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M9257", "InterventionBrowseLeafName":"Ketamine", "InterventionBrowseLeafAsFound":"Ketamine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16890", "InterventionBrowseLeafName":"Propofol", "InterventionBrowseLeafAsFound":"Propofol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8626", "InterventionBrowseLeafName":"Hypnotics and Sedatives", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19350", "InterventionBrowseLeafName":"Anesthetics, Intravenous", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19345", "InterventionBrowseLeafName":"Anesthetics, General", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2689", "InterventionBrowseLeafName":"Anesthetics, Dissociative", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19355", "InterventionBrowseLeafName":"Excitatory Amino Acid Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } } } } } }