{
  "FullStudy":{
    "Rank":217652,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518608",
          "OrgStudyIdInfo":{
            "OrgStudyId":"29237403/SMR-1651"
          },
          "Organization":{
            "OrgFullName":"Oslo University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach",
          "OfficialTitle":"Alfentanil and the Elimination of Sympathetic Responses to Tracheal Intubation During Rapid Sequence Induction of Anesthesia: A Probability-based Approach"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"August 25, 2011",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 25, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 26, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Oslo University Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University Hospital, Aker",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Induction of anesthesia:\n\nAfter 3 minutes pre-oxygenation with 100% oxygen, a blinded dose alfentanil (0,10,20,30,40,50 or 60 µg/kg, followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered over 15 sec. Laryngoscopy will be performed 40 s. after injection of rocuronium, with the goal being to have the endotracheal tube passed through the patients vocal cords and the cuff inflated within the following 15 s . The investigator performing the tracheal intubation is blinded to the dose of alfentanil administered.\n\nBlood samples:\n\nAs part of the study efficacy, blood samples, will be collected prior to induction and 30 s., 1 min. 3 min. and 5 min postintubation to determine blood concentrations of alfentanil and catecholamines.",
          "DetailedDescription":"Introduction:\n\nAutonomic responses (blood pressure and heart rate increases) secondary to tracheal intubation are probably not harmful to healthy individuals(1). However, in certain groups of patients (cardiac/neurosurgical/ophthalmic surgery), strict control of these responses during anesthesia may add to the safety of patient care (2-6).\n\nTraditionally, rapid sequence induction (RSI) of anesthesia is performed with combined administration of pentothal and suxamethonium. Significant increases in blood pressure and heart rate will be observed in most patients when this drug regimen is used(7-9). Opioid drugs may obtund autonomic responses to tracheal stimulation(10), but at present there is no consensus regarding the use of opioids as an integral part of the RSI of anesthesia.\n\nAIMS & OBJECTIVES:\n\nDefine guidelines for proper care of cardiac/neurosurgical/eye surgery patients during induction of anesthesia when rapid airway control is needed.\nDetermine the dose of alfentanil needed to prevent blood pressure and heart rate increases > 10% secondary to tracheal intubation performed in a rapid-sequence fashion (intubation completed within 70 s after start of drug administration: alfentanil-pentothal 4 mg/kg-rocuronium 0.6 mg/kg).\nDetermine the optimal dose of alfentanil to obtain perfect conditions for tracheal intubation in healthy surgical patients when laryngoscopy is initiated within 55 s after start of drug administration (alfentanil-pentothal 4 mg/kg-rocuronium 0,6 mg/kg).\n\nInduction of anesthesia:\n\nAfter 3 min pre-oxygenation with 100% oxygen, a blinded dose of alfentanil (0, 10, 20, 30, 40, 50 or 60 mcg/kg), followed by thiopental 4 mg/kg and rocuronium 0.6 mg/kg will be administered over 15 s. Cricoid pressure will be applied when the patient is unconscious.\n\nLaryngoscopy and intubation:\n\nLaryngoscopy will be performed 40 s after injection of rocuronium, with the goal being to have the endotracheal tube passed through the patients vocal cords and the cuff inflated within the following 15 s. The investigator performing the tracheal intubation will be blinded to the dose of alfentanil administered.\n\nMaintenance of anesthesia:\n\nThe study ends 5 min post intubation. At this time sevoflurane and fentanyl will be administered according to the patient's needs. Ventilation will be adjusted to pCO2-values in the range 4.5-6 kPa, and body temperature maintained at > 36 degree ºC with a forced-air warmer.\n\nMonitoring:\n\nRoutine monitoring of blood pressure, ECG, and pulse oximetry, according to standard of anaesthesia, approved by the Society of the Norwegian Anaesthesiologists. An arterial line will be inserted in one of the radial arteries for accurate beat-to-beat recording of blood pressure and heart rate, and for collection of blood samples.\n\nStatistical analysis plan:\n\nIn the present study a nonlinear logistic regression analysis will be used to determine the optimal dose of alfentanil based on the success rates of optimal blood pressure control (blood pressure increase < 10%)and the success rates of perfect intubation conditions in all alfentanil dose groups."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Anesthesia Intubation Complication"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Alfentanil",
              "Tracheal intubation",
              "Rapid sequence induction"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"84",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)",
                "InterventionDescription":"Induction dose(0µg/kg,10µg/kg,20µg/kg,30µg/kg,40µg/kg,50µg/Kg,and 60µg/kg) 12 patients in each dose group.\n\nPentothal 4mg/kg Rocuronium 0.6 mg/kg"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Alfentanil and blockage of sympathetic responses: A dose-response study.",
                "PrimaryOutcomeDescription":"Effectivness of controling Blood pressure during intubation",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nASA I and II patients and admitted for elective surgery.\nAged 18-55 years\nWritten informed consent\n\nExclusion Criteria:\n\nBody Mass Index (BMI) > 28 Kg/m²\nPatients with known allergy to study drug\nPatients with known porphyria\nNeuromuscular disease or undergoing treatment with drugs known to interfere with neuromuscular transmission.\nMallampati class > 2airway anatomy, or anticipated difficulty with mask ventilation or tracheal intubation.\nNeuromuscular disease\nPulmonary disease\nCardiovascular disease.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tom Heier, MD, Phd.",
                "OverallOfficialAffiliation":"University of Oslo",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Oslo University Hospital/ Aker",
                "LocationCity":"Oslo",
                "LocationState":"Akershus",
                "LocationZip":"0514",
                "LocationCountry":"Norway"
              },{
                "LocationFacility":"Oslo University Hospital / Aker",
                "LocationCity":"Oslo",
                "LocationZip":"0514",
                "LocationCountry":"Norway"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26176994",
                "ReferenceType":"derived",
                "ReferenceCitation":"Abou-Arab MH, Feiner JR, Spigset O, Heier T. Alfentanil during rapid sequence induction with thiopental 4 mg/kg and rocuronium 0.6 mg/kg: tracheal intubation conditions. Acta Anaesthesiol Scand. 2015 Nov;59(10):1278-86. doi: 10.1111/aas.12584. Epub 2015 Jul 14."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000015760",
                "InterventionMeshTerm":"Alfentanil"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000701",
                "InterventionAncestorTerm":"Analgesics, Opioid"
              },{
                "InterventionAncestorId":"D000009294",
                "InterventionAncestorTerm":"Narcotics"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000000700",
                "InterventionAncestorTerm":"Analgesics"
              },{
                "InterventionAncestorId":"D000018689",
                "InterventionAncestorTerm":"Sensory System Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000018686",
                "InterventionAncestorTerm":"Anesthetics, Intravenous"
              },{
                "InterventionAncestorId":"D000018681",
                "InterventionAncestorTerm":"Anesthetics, General"
              },{
                "InterventionAncestorId":"D000000777",
                "InterventionAncestorTerm":"Anesthetics"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M16903",
                "InterventionBrowseLeafName":"Alfentanil",
                "InterventionBrowseLeafAsFound":"Alfentanil",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2614",
                "InterventionBrowseLeafName":"Analgesics, Opioid",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2613",
                "InterventionBrowseLeafName":"Analgesics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M10828",
                "InterventionBrowseLeafName":"Narcotics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19350",
                "InterventionBrowseLeafName":"Anesthetics, Intravenous",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19345",
                "InterventionBrowseLeafName":"Anesthetics, General",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Analg",
                "InterventionBrowseBranchName":"Analgesics"
              },{
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}