{
  "FullStudy":{
    "Rank":218129,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512355",
          "OrgStudyIdInfo":{
            "OrgStudyId":"4-2011-0466"
          },
          "Organization":{
            "OrgFullName":"Yonsei University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 15, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 16, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Yonsei University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Postoperative agitation in children is a well-documented clinical phenomenon with incidence ranging from 10% to 67%. Recently, dexmedetomidine has been investigated extensively in the pediatric population and there is now increasing evidence to support the use of this drug as sedative and anesthetic adjunct in children. The purpose of this study is to determine whether prophylactic use of intraoperative dexmedetomidine to prevent of emergence delirium."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Strabismus"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"88",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"dexmedetomidine",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Dexmedetomidine"
                  ]
                }
              },{
                "ArmGroupLabel":"placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: placebo group"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Dexmedetomidine",
                "InterventionDescription":"After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "dexmedetomidine"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"placebo group",
                "InterventionDescription":"normal saline_02mcg/kg/hr",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"objective pain score",
                "PrimaryOutcomeDescription":"1. Objective pain score(OPS) Blood pressure 0~2 points crying 0~2points movement 0~2points agitation 0~2points posture 0~2points complain of pain(where appropiraate by age) 0~2points total 0~10 points",
                "PrimaryOutcomeTimeFrame":"immediate postoperative period up to 1hour after surgery"
              },{
                "PrimaryOutcomeMeasure":"pediatric anesthesia emergence delirium (PAED) scale",
                "PrimaryOutcomeDescription":"2. pediatric anesthesia emergence delirium (PAED) scale The Child makes eye contact with the caregiver 0~4 The child's actions are purposeful. 0~4 The child is aware of his'her surroundings. 0~4 The child is restless. 0~4 The child is insonsolable. 0~4 total 0~20 points",
                "PrimaryOutcomeTimeFrame":"immediate postoperative period up to 1hour after surgery"
              },{
                "PrimaryOutcomeMeasure":"5-point agitation scale",
                "PrimaryOutcomeDescription":"3. Scoring system for emergence agitation (behavior score)\n\nSleeping\nAwake and calm\nIrritable and crying\nInconsolable crying\nSevere restlessness and disorientation",
                "PrimaryOutcomeTimeFrame":"immediate postoperative period up to 1hour after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nthe patient undergoing the strabismus surgery in severance hospital\n\nExclusion Criteria:\n\ndelayed development\nmental retardation\ncerebral palsy\npreoperative EKG abnormality e.g. cardiovascular conduction disorder",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"5 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Severance Hospital",
                "LocationCity":"Seoul",
                "LocationZip":"120-752",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000020927",
                "InterventionMeshTerm":"Dexmedetomidine"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000006993",
                "InterventionAncestorTerm":"Hypnotics and Sedatives"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018712",
                "InterventionAncestorTerm":"Analgesics, Non-Narcotic"
              },{
                "InterventionAncestorId":"D000000700",
                "InterventionAncestorTerm":"Analgesics"
              },{
                "InterventionAncestorId":"D000018689",
                "InterventionAncestorTerm":"Sensory System Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000058647",
                "InterventionAncestorTerm":"Adrenergic alpha-2 Receptor Agonists"
              },{
                "InterventionAncestorId":"D000000316",
                "InterventionAncestorTerm":"Adrenergic alpha-Agonists"
              },{
                "InterventionAncestorId":"D000000322",
                "InterventionAncestorTerm":"Adrenergic Agonists"
              },{
                "InterventionAncestorId":"D000018663",
                "InterventionAncestorTerm":"Adrenergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M21246",
                "InterventionBrowseLeafName":"Dexmedetomidine",
                "InterventionBrowseLeafAsFound":"Dexmedetomidine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8626",
                "InterventionBrowseLeafName":"Hypnotics and Sedatives",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2613",
                "InterventionBrowseLeafName":"Analgesics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19370",
                "InterventionBrowseLeafName":"Analgesics, Non-Narcotic",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19330",
                "InterventionBrowseLeafName":"Adrenergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2249",
                "InterventionBrowseLeafName":"Adrenergic alpha-Agonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2254",
                "InterventionBrowseLeafName":"Adrenergic Agonists",
                "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"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013285",
                "ConditionMeshTerm":"Strabismus"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000015835",
                "ConditionAncestorTerm":"Ocular Motility Disorders"
              },{
                "ConditionAncestorId":"D000003389",
                "ConditionAncestorTerm":"Cranial Nerve Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5477",
                "ConditionBrowseLeafName":"Delirium",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14658",
                "ConditionBrowseLeafName":"Strabismus",
                "ConditionBrowseLeafAsFound":"Strabismus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13035",
                "ConditionBrowseLeafName":"Psychomotor Agitation",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M772",
                "ConditionBrowseLeafName":"Emergence Delirium",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16969",
                "ConditionBrowseLeafName":"Ocular Motility Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5188",
                "ConditionBrowseLeafName":"Cranial Nerve Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              }
            ]
          }
        }
      }
    }
  }
}