{
  "FullStudy":{
    "Rank":218020,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513772",
          "OrgStudyIdInfo":{
            "OrgStudyId":"4-2011-0742"
          },
          "Organization":{
            "OrgFullName":"Severance Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 7, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 9, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"So Yeon Kim",
            "ResponsiblePartyInvestigatorTitle":"Clinical assistant professor",
            "ResponsiblePartyInvestigatorAffiliation":"Severance Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Severance Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery",
          "DetailedDescription":"Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Airway Extubation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Normal saline 0.9%"
                  ]
                }
              },{
                "ArmGroupLabel":"Dexmedetomidine",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Dexmedetomidine"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Dexmedetomidine",
                "InterventionDescription":"Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dexmedetomidine"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Normal saline 0.9%",
                "InterventionDescription":"Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Emergence agitation",
                "PrimaryOutcomeTimeFrame":"20min"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Postoperative quality of recovery",
                "SecondaryOutcomeTimeFrame":"1 day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nage ≥ 20,\nASA class I and II,\nnasal surgery\n\nExclusion Criteria:\n\nbradycardia (< 45 bpm),\nheart block,\nliver failure,\nrenal failure,\nuncontrolled hypertension,\nbody mass index ≥ 30 kg/m2",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"59 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine",
                "LocationCity":"Seoul",
                "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":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13035",
                "ConditionBrowseLeafName":"Psychomotor Agitation",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M772",
                "ConditionBrowseLeafName":"Emergence Delirium",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}