Nctid:
NCT06228729
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000072836", "term"=>"Surgical Wound"}], "ancestors"=>[{"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M1112", "name"=>"Surgical Wound", "asFound"=>"Surgical Incision", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>52}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-07-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-12", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-14", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Association between band power changes in EEG and hormone respones caused by endotracheal intubation", "timeFrame"=>"from the start of anesthesia induction to one minute after endotracheal intubation"}], "secondaryOutcomes"=>[{"measure"=>"Association between band power changes in EEG and hormone respones caused by surgical incision", "timeFrame"=>"from the start of anesthesia induction to one minute after surgical incision"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Abdominal Surgery", "Endotracheal Intubation", "Surgical Incision", "Electroencephalogram"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to prospectively evaluate the relationship between changes in EEG and hormonal responses induced by endotracheal intubation and surgical incision following general anesthesia.", "detailedDescription"=>"This study aims to investigate the relationship between changes in EEG patterns and stress hormone levels in patients undergoing open abdominal surgery under general anesthesia when subjected to endotracheal intubation and surgical incision stimuli.\n\nHormone measurements (cortisol, ACTH) are taken at four time points: before endotracheal intubation (T1), one minute after intubation (T2), and one minute after surgical incision (T3). The investigators evaluate the correlation between hormone levels (cortisol, ACTH) and EEG band power changes (alpha, beta, delta) before and after endotracheal intubation and surgical incision."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"20 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Adult patients undergoing open abdominal surgery and endotracheal intubation under general anesthesia", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 1) Patients scheduled to undergo open abdominal surgery under general anesthesia with endotracheal intubation.\n* 2) Patients requiring invasive blood pressure monitoring during surgery\n\nExclusion Criteria:\n\n* 1) Patients transferred to the intensive care unit after surgery\n* 2) Surgery duration of less than one hour\n* 3) Patients with neurological underlying conditions\n* 4) Patients on chronic use of psychotropic medications and opioid drugs\n* 5) Emergency surgery"}, "identificationModule"=>{"nctId"=>"NCT06228729", "briefTitle"=>"Association Between EEG Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation", "organization"=>{"class"=>"OTHER", "fullName"=>"Seoul National University Hospital"}, "officialTitle"=>"Evaluation of the Association Between Electroencephalographic Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation in Abdominal Surgery: a Prospective Observational Study", "orgStudyIdInfo"=>{"id"=>"2311-093-1484"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Endotracheal intubation", "type"=>"PROCEDURE", "description"=>"Inserting endotracheal tube into the trachea"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Seoul National University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Clinical assistant professor", "investigatorFullName"=>"Hyun-Kyu Yoon", "investigatorAffiliation"=>"Seoul National University Hospital"}}}}
