{
  "FullStudy":{
    "Rank":217703,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517932",
          "OrgStudyIdInfo":{
            "OrgStudyId":"TJMU-A-201106"
          },
          "Organization":{
            "OrgFullName":"Huazhong University of Science and Technology",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia",
          "OfficialTitle":"Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 22, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 18, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 20, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Fang Luo",
            "ResponsiblePartyInvestigatorTitle":"Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology",
            "ResponsiblePartyInvestigatorAffiliation":"Huazhong University of Science and Technology"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Fang Luo",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.\n\nIn this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.",
          "DetailedDescription":"Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Restlessness",
              "Pain"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"60",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Group-DEX",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: dexmedetomidine"
                  ]
                }
              },{
                "ArmGroupLabel":"Group-PLB",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: saline placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"dexmedetomidine",
                "InterventionDescription":"In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.\n\nAnaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.\n\nPatients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group-DEX"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"saline placebo",
                "InterventionDescription":"In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.\n\nAnaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.\n\nPatients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group-PLB"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Emergence agitation",
                "PrimaryOutcomeDescription":"Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours",
                "PrimaryOutcomeTimeFrame":"during 0-3 postoperative hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Postoperative pain at rest",
                "SecondaryOutcomeDescription":"The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale（VAS）and prince-henry score",
                "SecondaryOutcomeTimeFrame":"At 1,3 postoperative hours"
              },{
                "SecondaryOutcomeMeasure":"dosage Dosage of analgesics",
                "SecondaryOutcomeTimeFrame":"during 3 postoperative hours"
              },{
                "SecondaryOutcomeMeasure":"Recovery time",
                "SecondaryOutcomeTimeFrame":"At the moment of the eyes opend when calling the names"
              },{
                "SecondaryOutcomeMeasure":"Postoperative sedation",
                "SecondaryOutcomeDescription":"It was assessed by Ramsay Sedation Score(RSS)",
                "SecondaryOutcomeTimeFrame":"at 0,1,3 postoperative hours"
              },{
                "SecondaryOutcomeMeasure":"Extubation time",
                "SecondaryOutcomeTimeFrame":"at the moment of extubation"
              },{
                "SecondaryOutcomeMeasure":"Breathing recovery time",
                "SecondaryOutcomeTimeFrame":"when autonomous respiration recovered"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAmerican Society of Anaesthesiologists Physical Status (ASA-PS) I or II\nundergoing selective thoracotomy\nweight between 45 and 75kg\noperation time 2-4 hours\n\nExclusion Criteria:\n\nhistory of neurologic disease\nhistory of chronic analgesics intake\nhistory of allergic reactions to the experimental durgs\nhistory of renal insufficiency\nhistory of hepatic dysfunction\nhistory of coagulation disorders\nwomen in lactation\nparticipating in other studies",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Fang Luo, MD.PhD",
                "OverallOfficialAffiliation":"Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China",
                "OverallOfficialRole":"Study Director"
              }
            ]
          }
        }
      },
      "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":"D000011595",
                "ConditionMeshTerm":"Psychomotor Agitation"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020820",
                "ConditionAncestorTerm":"Dyskinesias"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000011596",
                "ConditionAncestorTerm":"Psychomotor Disorders"
              },{
                "ConditionAncestorId":"D000019954",
                "ConditionAncestorTerm":"Neurobehavioral Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13035",
                "ConditionBrowseLeafName":"Psychomotor Agitation",
                "ConditionBrowseLeafAsFound":"Restlessness",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21158",
                "ConditionBrowseLeafName":"Dyskinesias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13036",
                "ConditionBrowseLeafName":"Psychomotor Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20410",
                "ConditionBrowseLeafName":"Neurobehavioral Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}