{
  "FullStudy":{
    "Rank":218117,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512511",
          "OrgStudyIdInfo":{
            "OrgStudyId":"u-89140"
          },
          "Organization":{
            "OrgFullName":"Ahvaz Jundishapur University of Medical Sciences",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy",
          "OfficialTitle":"Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 3, 2012",
          "StudyFirstSubmitQCDate":"January 15, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 15, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Mehdi Asgari",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Ahvaz Jundishapur University of Medical Sciences"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ahvaz Jundishapur University of Medical Sciences",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common use, has not compared to N2O sufficiently to disclose which one has minimal \"physiological\" invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and compared."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pneumoperitoneum"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "laparoscopic cholecystectomy",
              "pneumoperitoneum",
              "nitrous oxide",
              "carbon dioxide"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"64",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"nitrous oxide",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"use nitrous oxide for pneumoperitoneum creation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: nitrous oxide use for pneumoperitoneum creation"
                  ]
                }
              },{
                "ArmGroupLabel":"carbon dioxide",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"use carbon dioxide for pneumoperitoneum creation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: nitrous oxide use for pneumoperitoneum creation"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"nitrous oxide use for pneumoperitoneum creation",
                "InterventionDescription":"use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "carbon dioxide",
                    "nitrous oxide"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"heart rate",
                "PrimaryOutcomeDescription":"number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.",
                "PrimaryOutcomeTimeFrame":"At the start of laparoscopic surgery and Immediately after surgery."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Mean arterial pressure",
                "SecondaryOutcomeDescription":"average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery",
                "SecondaryOutcomeTimeFrame":"At the start of laparoscopic surgery and Immediately after surgery."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ndeveloped gallstones\ncandidates for laparoscopic cholecystectomy\nwritten informed consent\nASA Score = 1&2\n\nExclusion Criteria:\n\nsigns and complications of gallstones in admission include acute cholecystitis and suppurative cholangitis\ncomplete Inability to move\nsevere physical or mental disorders leading to inability to communicate -Pregnancy and\ncancer",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Mehdi Asgari, PhD",
                "OverallOfficialAffiliation":"Ahvaz Jundishapur University of Medical Sciences",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Ahvaz jundishapur university of medical sciences; Razi Hospital",
                "LocationCity":"Ahvaz",
                "LocationState":"Khuzestan",
                "LocationCountry":"Iran, Islamic Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000009609",
                "InterventionMeshTerm":"Nitrous Oxide"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "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"
              },{
                "InterventionAncestorId":"D000018712",
                "InterventionAncestorTerm":"Analgesics, Non-Narcotic"
              },{
                "InterventionAncestorId":"D000000700",
                "InterventionAncestorTerm":"Analgesics"
              },{
                "InterventionAncestorId":"D000018689",
                "InterventionAncestorTerm":"Sensory System Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M11129",
                "InterventionBrowseLeafName":"Nitrous Oxide",
                "InterventionBrowseLeafAsFound":"Nitrous Oxide",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19349",
                "InterventionBrowseLeafName":"Anesthetics, Inhalation",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19345",
                "InterventionBrowseLeafName":"Anesthetics, General",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2613",
                "InterventionBrowseLeafName":"Analgesics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19370",
                "InterventionBrowseLeafName":"Analgesics, Non-Narcotic",
                "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":"D000011027",
                "ConditionMeshTerm":"Pneumoperitoneum"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010532",
                "ConditionAncestorTerm":"Peritoneal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12500",
                "ConditionBrowseLeafName":"Pneumoperitoneum",
                "ConditionBrowseLeafAsFound":"Pneumoperitoneum",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12024",
                "ConditionBrowseLeafName":"Peritoneal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}