{
  "FullStudy":{
    "Rank":217863,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515852",
          "OrgStudyIdInfo":{
            "OrgStudyId":"JohannWGUH_GALAXY"
          },
          "Organization":{
            "OrgFullName":"Johann Wolfgang Goethe University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"General Anesthesia vs. Local Anesthesia in Stereotaxy",
          "OfficialTitle":"General Anesthesia vs. Local Anesthesia in Stereotaxy",
          "Acronym":"GALAXY"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2013",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2014",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 20, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 21, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Lutz Weise",
            "ResponsiblePartyInvestigatorTitle":"Lutz Weise, M. D. Goethe University",
            "ResponsiblePartyInvestigatorAffiliation":"Johann Wolfgang Goethe University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Johann Wolfgang Goethe University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy",
          "DetailedDescription":"Stereotactic biopsy is routinely performed under local or general anesthesia. The advantage of local anesthesia might be reduction in cardiac and pulmonal complications, reduction of surgical time, and reduction of hospital stay. On the other hand it has been postulated that intraoperative seizures are avoided by general anesthesia and that brain tumor surgery is perceived in the public as psychological and physical stress.Therefor we postulate that patients undergoing stereotactic biopsies in local anesthesia show a higher stress level than patients operated under general anesthesia."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Brain Lesion, Stereotactic Biopsy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "stress level",
              "stereotactic biopsy",
              "brain lesion",
              "general anesthesia",
              "local anesthesia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"80",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Stress level after general anesthesia",
                "ArmGroupType":"Other",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: general anesthesia in stereotactic biopsy"
                  ]
                }
              },{
                "ArmGroupLabel":"Stress level after local anesthesia",
                "ArmGroupType":"Other",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: local anesthesia in stereotactic biopsy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"general anesthesia in stereotactic biopsy",
                "InterventionDescription":"stereotactic biopsy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Stress level after general anesthesia"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"local anesthesia in stereotactic biopsy",
                "InterventionDescription":"stereotactic biopsy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Stress level after local anesthesia"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"PTSS-10",
                "PrimaryOutcomeTimeFrame":"Three days after operation"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nplanned stereotactic biopsy\nage > 18 years\n\nExclusion Criteria:\n\npregnancy\nanxiety disorder\nimpaired consciousness",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Lutz Weise, M. D.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"(0049) 69 6301",
                "CentralContactPhoneExt":"5939",
                "CentralContactEMail":"lutz.weise@med.uni-frankfurt.de"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Neurosurgery, Johann Wolfgang Goethe University",
                "LocationStatus":"Recruiting",
                "LocationCity":"Frankfurt am Main",
                "LocationZip":"60528",
                "LocationCountry":"Germany",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Lutz Weise, M. D.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"(0049) 69 6301",
                      "LocationContactPhoneExt":"5939",
                      "LocationContactEMail":"lutz.weise@med.uni-frankfurt.de"
                    },{
                      "LocationContactName":"Lutz Weise, M. D.",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000000777",
                "InterventionMeshTerm":"Anesthetics"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafAsFound":"Anesthesia",
                "InterventionBrowseLeafRelevance":"high"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}