Nctid:
NCT06612996
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014648", "term"=>"Varicose Veins"}, {"id"=>"D000014647", "term"=>"Varicose Ulcer"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000007871", "term"=>"Leg Ulcer"}, {"id"=>"D000012883", "term"=>"Skin Ulcer"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M17206", "name"=>"Ulcer", "relevance"=>"LOW"}, {"id"=>"M9625", "name"=>"Hernia", "relevance"=>"LOW"}, {"id"=>"M17396", "name"=>"Varicose Veins", "asFound"=>"Varicose Veins", "relevance"=>"HIGH"}, {"id"=>"M17395", "name"=>"Varicose Ulcer", "asFound"=>"Venous Ulcers", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M10883", "name"=>"Leg Ulcer", "relevance"=>"LOW"}, {"id"=>"M15686", "name"=>"Skin Ulcer", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008278", "term"=>"Magnesium Sulfate"}, {"id"=>"D000014147", "term"=>"Tramadol"}], "ancestors"=>[{"id"=>"D000000701", "term"=>"Analgesics, Opioid"}, {"id"=>"D000009294", "term"=>"Narcotics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000000889", "term"=>"Anti-Arrhythmia Agents"}, {"id"=>"D000000927", "term"=>"Anticonvulsants"}, {"id"=>"D000002121", "term"=>"Calcium Channel Blockers"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D000015149", "term"=>"Tocolytic Agents"}, {"id"=>"D000012102", "term"=>"Reproductive Control Agents"}], "browseLeaves"=>[{"id"=>"M11270", "name"=>"Magnesium Sulfate", "asFound"=>"Shock", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M16901", "name"=>"Tramadol", "asFound"=>"Members", "relevance"=>"HIGH"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M4213", "name"=>"Anti-Arrhythmia Agents", "relevance"=>"LOW"}, {"id"=>"M4246", "name"=>"Anticonvulsants", "relevance"=>"LOW"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M5384", "name"=>"Calcium Channel Blockers", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M17869", "name"=>"Tocolytic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Anticonvulsants", "abbrev"=>"AntiConv"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>180}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-01-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Shivering score", "timeFrame"=>"90 minutes postoperatively", "description"=>"Shivering score"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Tramadol", "Magnesium Sulphate", "Shivering"], "conditions"=>["Lower Extremity Chronic Venous Ulcers", "Varicose Veins Leg", "Hernia"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.\n\nExclusion Criteria:\n\n* history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \\>38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake"}, "identificationModule"=>{"nctId"=>"NCT06612996", "briefTitle"=>"Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering", "organization"=>{"class"=>"OTHER", "fullName"=>"Al-Azhar University"}, "officialTitle"=>"Comparative Study Between Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering Post Intrathecal Anesthesia a Randomized Clinical Study", "orgStudyIdInfo"=>{"id"=>"AZAST/19/14-May-2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Tramadol group", "description"=>"Intravenous Tramadol", "interventionNames"=>["Drug: Tramadol"]}, {"type"=>"EXPERIMENTAL", "label"=>"Magnesium sulphate group", "description"=>"Intravenous Magnesium Sulphate", "interventionNames"=>["Drug: Magnesium sulphate"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"Saline", "interventionNames"=>["Other: Saline"]}], "interventions"=>[{"name"=>"Tramadol", "type"=>"DRUG", "description"=>"Intravenous tramadol", "armGroupLabels"=>["Tramadol group"]}, {"name"=>"Magnesium sulphate", "type"=>"DRUG", "description"=>"Intravenous magnesium sulphate", "armGroupLabels"=>["Magnesium sulphate group"]}, {"name"=>"Saline", "type"=>"OTHER", "description"=>"Normal saline", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Warda Demerdash Ali, PhD", "role"=>"CONTACT", "email"=>"warda2001@hotmail.com", "phone"=>"088 2148087"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Al-Azhar University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr", "investigatorFullName"=>"Warda Demerdash Khalifa Ali", "investigatorAffiliation"=>"Al-Azhar University"}}}}
