Nctid:
NCT06233435
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Prospective study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>33}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-01-24", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10-19", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty", "timeFrame"=>"at 6 and 24 hours after total knee arthroplasty"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Total Knee Arthroplasty"]}, "descriptionModule"=>{"briefSummary"=>"This study is a prospective study which compares of Modified Post-Anesthetic Discharge Scoring System (PADSS) between 6 and 24 hours in patients undergoing total knee arthroplasty in Thammasat University hospital, Thailand."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient undergoing total knee arthroplasty (one side) under spinal block with adductor canal block\n* 18-85 years old\n* American Society of Anesthesiologist physical status classification I-III\n\nExclusion Criteria:\n\n* Allergy to local anesthetic drugs"}, "identificationModule"=>{"nctId"=>"NCT06233435", "briefTitle"=>"Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty", "organization"=>{"class"=>"OTHER", "fullName"=>"Thammasat University Hospital"}, "officialTitle"=>"Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 6 and 24 Hours in Patients Undergoing Total Knee Arthroplasty", "orgStudyIdInfo"=>{"id"=>"MTU-EC-AN-2-179/66"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"PADSS at 6 hours", "interventionNames"=>["Behavioral: PADSS"]}, {"type"=>"OTHER", "label"=>"PADSS at 24 hours", "interventionNames"=>["Behavioral: PADSS"]}], "interventions"=>[{"name"=>"PADSS", "type"=>"BEHAVIORAL", "description"=>"Observe PADSS after total knee arthroplasty at 6 and 24 hours", "armGroupLabels"=>["PADSS at 24 hours", "PADSS at 6 hours"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12120", "city"=>"Pathumthani", "state"=>"Klong Luang", "status"=>"RECRUITING", "country"=>"Thailand", "contacts"=>[{"name"=>"Niruji Saengsomsuan", "role"=>"CONTACT", "email"=>"jns_owen@hotmail.com", "phone"=>"+66814295524"}], "facility"=>"Thammasat University hospital", "geoPoint"=>{"lat"=>14.01346, "lon"=>100.53049}}], "centralContacts"=>[{"name"=>"Niruji Saengsomsuan, MD", "role"=>"CONTACT", "email"=>"jns_owen@hotmail.com", "phone"=>"+66814295524"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Thammasat University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Anesthesiology", "investigatorFullName"=>"Niruji Saengsomsuan", "investigatorAffiliation"=>"Thammasat University Hospital"}}}}
