{
  "FullStudy":{
    "Rank":218157,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511991",
          "OrgStudyIdInfo":{
            "OrgStudyId":"KUH1160037"
          },
          "Organization":{
            "OrgFullName":"Konkuk University Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery",
          "OfficialTitle":"Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 20, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 24, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Tae-Yop Kim, MD PhD",
            "ResponsiblePartyInvestigatorTitle":"Professor of Anesthesiology",
            "ResponsiblePartyInvestigatorAffiliation":"Konkuk University Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Konkuk University Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine sevoflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different sevoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery patients.",
          "DetailedDescription":"Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):\n\nTDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')\ntransmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;\nLV-ejection fraction (EF)\nbispectral index (BIS)\nphenylephrine-infusion rate\nother pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Valvular Heart Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "cardiac surgery",
              "sevoflurane",
              "tissue Doppler"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Early Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"sevoflurane",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Sevoflurane dosage titration"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Sevoflurane dosage titration",
                "InterventionDescription":"comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "sevoflurane"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "sevorane"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Peak mitral annular velocity during systole (S')",
                "PrimaryOutcomeDescription":"By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "PrimaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%"
              },{
                "PrimaryOutcomeMeasure":"Peak mitral annular velocity during early filling (E')",
                "PrimaryOutcomeDescription":"By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "PrimaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%"
              },{
                "PrimaryOutcomeMeasure":"peak mitral annular velocity during atrial contraction(A')",
                "PrimaryOutcomeDescription":"By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, A' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "PrimaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"ejection fraction (EF)",
                "SecondaryOutcomeDescription":"By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "SecondaryOutcomeTimeFrame":"after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%"
              },{
                "SecondaryOutcomeMeasure":"bispectral index (BIS)",
                "SecondaryOutcomeDescription":"BIS would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "SecondaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%"
              },{
                "SecondaryOutcomeMeasure":"peak velocity of mitral inflow during early relaxation (E)",
                "SecondaryOutcomeDescription":"By using pulsed Doppler with the sample volume positioned at the lMV opening in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "SecondaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%"
              },{
                "SecondaryOutcomeMeasure":"peak velocity of mitral inflow during atrial contraction (A)",
                "SecondaryOutcomeDescription":"By using pulsed Doppler with the sample volume positioned at the tip of MV oeneing in the midesophageal 4-chamber view, \"A\" would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)",
                "SecondaryOutcomeTimeFrame":"after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npatients undergoing cardiac surgery\n\nExclusion Criteria:\n\nlow ejection fraction < 50% in preoperative transthoracic echocardiography\natrial fibrillation\npacemaker\npericardial and infiltrative myocardial disease\nmitral annular calcification, surgical rings, prosthetic mitral valves\nlateral left ventricular regional wall motion abnormality\nesophageal spasm,stricture, laceration, perforation, and diverticulum\ndiaphragmatic hernia,\nhistory of extensive radiation to the mediastinum\nupper gastrointestinal bleeding",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tae-Yop Kim, MD PhD",
                "OverallOfficialAffiliation":"Konkuk University Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Konkuk University Medical Center",
                "LocationCity":"Seoul",
                "LocationZip":"143-729",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"14566295",
                "ReferenceType":"background",
                "ReferenceCitation":"Bruch C, Gradaus R, Gunia S, Breithardt G, Wichter T. Doppler tissue analysis of mitral annular velocities: evidence for systolic abnormalities in patients with diastolic heart failure. J Am Soc Echocardiogr. 2003 Oct;16(10):1031-6."
              },{
                "ReferencePMID":"11734780",
                "ReferenceType":"background",
                "ReferenceCitation":"Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. Review."
              }
            ]
          }
        }
      },
      "AnnotationSection":{
        "AnnotationModule":{
          "UnpostedAnnotation":{
            "UnpostedResponsibleParty":"Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center",
            "UnpostedEventList":{
              "UnpostedEvent":[
                {
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"June 17, 2015"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"July 17, 2015"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"September 7, 2015"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"October 7, 2015"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"February 5, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"March 3, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"March 28, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"April 28, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"August 29, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"October 20, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"October 21, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"December 14, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"March 1, 2017"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"April 11, 2017"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"March 19, 2018"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"November 1, 2018"
                }
              ]
            }
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077149",
                "InterventionMeshTerm":"Sevoflurane"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000010975",
                "InterventionAncestorTerm":"Platelet Aggregation Inhibitors"
              },{
                "InterventionAncestorId":"D000018685",
                "InterventionAncestorTerm":"Anesthetics, Inhalation"
              },{
                "InterventionAncestorId":"D000018681",
                "InterventionAncestorTerm":"Anesthetics, General"
              },{
                "InterventionAncestorId":"D000000777",
                "InterventionAncestorTerm":"Anesthetics"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1673",
                "InterventionBrowseLeafName":"Sevoflurane",
                "InterventionBrowseLeafAsFound":"Sevoflurane",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M12448",
                "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19349",
                "InterventionBrowseLeafName":"Anesthetics, Inhalation",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19345",
                "InterventionBrowseLeafName":"Anesthetics, General",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"PlAggInh",
                "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006331",
                "ConditionMeshTerm":"Heart Diseases"
              },{
                "ConditionMeshId":"D000006349",
                "ConditionMeshTerm":"Heart Valve Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafAsFound":"Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8020",
                "ConditionBrowseLeafName":"Heart Valve Diseases",
                "ConditionBrowseLeafAsFound":"Valvular Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}