{ "FullStudy":{ "Rank":217952, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514695", "OrgStudyIdInfo":{ "OrgStudyId":"R.P. 11-3611" }, "Organization":{ "OrgFullName":"St. Joseph's Healthcare Hamilton", "OrgClass":"OTHER" }, "BriefTitle":"Fentanyl Use for Sedation in Esophagogastroduodenoscopy", "OfficialTitle":"Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy", "Acronym":"FUSE" }, "StatusModule":{ "StatusVerifiedDate":"January 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 28, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 30, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Khurram Khan", "ResponsiblePartyInvestigatorTitle":"Assistant Professor of Medicine", "ResponsiblePartyInvestigatorAffiliation":"St. Joseph's Healthcare Hamilton" }, "LeadSponsor":{ "LeadSponsorName":"St. Joseph's Healthcare Hamilton", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"McMaster University", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.", "DetailedDescription":"Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative & narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Endoscopy" ] }, "KeywordList":{ "Keyword":[ "endoscopy", "sedation", "opioid", "narcotic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"139", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Fentanyl", "ArmGroupType":"Experimental", "ArmGroupDescription":"Fentanyl arm", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Midazolam", "Drug: Fentanyl" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo of identical appearance", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Midazolam", "Other: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Midazolam", "InterventionDescription":"Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Fentanyl", "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"Fentanyl", "InterventionDescription":"100mcg intravenously given in 2mL syringe at start of procedure", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Fentanyl" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"One dose of saline (2ml)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale", "PrimaryOutcomeDescription":"Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.", "PrimaryOutcomeTimeFrame":"Within 72 hours of procedure" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale", "SecondaryOutcomeTimeFrame":"Following procedure up to time of discharge (average of 45 minutes after procedure started)" },{ "SecondaryOutcomeMeasure":"Patient willingness to repeat procedure", "SecondaryOutcomeTimeFrame":"Asked within 72 hours of procedure" },{ "SecondaryOutcomeMeasure":"Presence of significant retching", "SecondaryOutcomeDescription":"Recorded by physician completing procedure", "SecondaryOutcomeTimeFrame":"Following procedure up to time of discharge (average of 45 minutes after procedure started)" },{ "SecondaryOutcomeMeasure":"Presence of adverse events", "SecondaryOutcomeDescription":"Any adverse event during procedure up until patient leaves endoscopy unit", "SecondaryOutcomeTimeFrame":"Following procedure up to time of discharge (average of 45 minutes after procedure started)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\noutpatient elective upper endoscopy\nage 18-65\nable to give consent\n\nExclusion Criteria:\n\nmental incompetency\npregnancy\nweight <55kg or 110 lbs\nemergent procedures,\nknown hypersensitivity or allergy to fentanyl or midazolam\nchronic use of benzodiazepines or opioids\npatients known a priori to require therapeutic interventions in conjunction with their EGD\npatients to have major cardiorespiratory comorbidities, obstructive sleep apnea, liver cirrhosis, or renal failure", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Khurram J Khan, MD, BSc, MSc", "OverallOfficialAffiliation":"St Joseph's Healthcare Hamilton, McMaster University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"St Joseph's Healthcare Hamilton", "LocationCity":"Hamilton", "LocationState":"Ontario", "LocationZip":"L8N4A6", "LocationCountry":"Canada" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000005283", "InterventionMeshTerm":"Fentanyl" },{ "InterventionMeshId":"D000008874", "InterventionMeshTerm":"Midazolam" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000701", "InterventionAncestorTerm":"Analgesics, Opioid" },{ "InterventionAncestorId":"D000009294", "InterventionAncestorTerm":"Narcotics" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000000759", "InterventionAncestorTerm":"Adjuvants, Anesthesia" },{ "InterventionAncestorId":"D000018686", "InterventionAncestorTerm":"Anesthetics, Intravenous" },{ "InterventionAncestorId":"D000018681", "InterventionAncestorTerm":"Anesthetics, General" },{ "InterventionAncestorId":"D000000777", "InterventionAncestorTerm":"Anesthetics" },{ "InterventionAncestorId":"D000006993", "InterventionAncestorTerm":"Hypnotics and Sedatives" },{ "InterventionAncestorId":"D000014151", "InterventionAncestorTerm":"Anti-Anxiety Agents" },{ "InterventionAncestorId":"D000014149", "InterventionAncestorTerm":"Tranquilizing Agents" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" },{ "InterventionAncestorId":"D000018757", "InterventionAncestorTerm":"GABA Modulators" },{ "InterventionAncestorId":"D000018682", "InterventionAncestorTerm":"GABA Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10428", "InterventionBrowseLeafName":"Midazolam", "InterventionBrowseLeafAsFound":"Midazolam", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M7001", "InterventionBrowseLeafName":"Fentanyl", "InterventionBrowseLeafAsFound":"Fentanyl", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2614", "InterventionBrowseLeafName":"Analgesics, Opioid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10828", "InterventionBrowseLeafName":"Narcotics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19350", "InterventionBrowseLeafName":"Anesthetics, Intravenous", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19345", "InterventionBrowseLeafName":"Anesthetics, General", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8626", "InterventionBrowseLeafName":"Hypnotics and Sedatives", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15488", "InterventionBrowseLeafName":"Anti-Anxiety Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19411", "InterventionBrowseLeafName":"GABA Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AdjAn", "InterventionBrowseBranchName":"Adjuvants, Anesthesia" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" } ] } } } } } }