Nctid:
NCT06614881
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003693", "term"=>"Delirium"}, {"id"=>"D000071257", "term"=>"Emergence Delirium"}], "ancestors"=>[{"id"=>"D000003221", "term"=>"Confusion"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M6894", "name"=>"Delirium", "asFound"=>"Delirium", "relevance"=>"HIGH"}, {"id"=>"M772", "name"=>"Emergence Delirium", "asFound"=>"Post-operative Delirium", "relevance"=>"HIGH"}, {"id"=>"M6446", "name"=>"Confusion", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000020927", "term"=>"Dexmedetomidine"}], "ancestors"=>[{"id"=>"D000006993", "term"=>"Hypnotics and Sedatives"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000058647", "term"=>"Adrenergic alpha-2 Receptor Agonists"}, {"id"=>"D000000316", "term"=>"Adrenergic alpha-Agonists"}, {"id"=>"D000000322", "term"=>"Adrenergic Agonists"}, {"id"=>"D000018663", "term"=>"Adrenergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M22662", "name"=>"Dexmedetomidine", "asFound"=>"Human", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M10043", "name"=>"Hypnotics and Sedatives", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M3668", "name"=>"Adrenergic alpha-Agonists", "relevance"=>"LOW"}, {"id"=>"M3673", "name"=>"Adrenergic Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>132}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.", "timeFrame"=>"3 months"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Post Operative Delirium"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"35 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;\n* Patients of American Society of Anesthesiologists Classification grades II-III;\n* Patients free of exclusion criteria.\n\nExclusion Criteria:\n\n* Patients of American Society of Anesthesiologists Classification grade \\>III;\n* Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;\n* Patients had a history of uncompensated cardiac, renal, or hepatic diseases;\n* Patients had uncontrolled diabetes mellitus or hypertension;\n* Patients had other causes for limited movement;\n* Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of \\<7 g%;\n* Patients had local bone disorders that may prevent prosthesis stability;\n* Patients had allergies or contraindications to the study drugs."}, "identificationModule"=>{"nctId"=>"NCT06614881", "briefTitle"=>"Dexmedetomidine Dosage for Postoperative Delirium and Cognitive Function in Elderly TKA Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Tanta University"}, "officialTitle"=>"Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery", "orgStudyIdInfo"=>{"id"=>"36264PR790/7/24"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Control Group", "interventionNames"=>["Drug: Normal saline"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group D-1", "interventionNames"=>["Drug: Dexmedetomidine Injection [Precedex]", "Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group D-2", "interventionNames"=>["Drug: Dexmedetomidine Injection [Precedex]", "Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group D-3", "interventionNames"=>["Drug: Dexmedetomidine Injection [Precedex]", "Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)"]}], "interventions"=>[{"name"=>"Dexmedetomidine Injection [Precedex]", "type"=>"DRUG", "description"=>"Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min", "armGroupLabels"=>["Group D-1", "Group D-2", "Group D-3"]}, {"name"=>"Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)", "type"=>"DRUG", "description"=>"Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h", "armGroupLabels"=>["Group D-1"]}, {"name"=>"Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)", "type"=>"DRUG", "description"=>"Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h", "armGroupLabels"=>["Group D-2"]}, {"name"=>"Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)", "type"=>"DRUG", "description"=>"Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h", "armGroupLabels"=>["Group D-3"]}, {"name"=>"Normal saline", "type"=>"DRUG", "description"=>"loading dose of saline was injected 10-min before induction of anesthesia.", "armGroupLabels"=>["Control Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"13511", "city"=>"Tanta", "state"=>"El Gharbyia", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Ali El Deeb, Professor", "role"=>"CONTACT", "email"=>"b.checked88@gmail.com", "phone"=>"01222800335", "phoneExt"=>"+2"}], "facility"=>"Tanta University", "geoPoint"=>{"lat"=>30.78847, "lon"=>31.00192}}], "centralContacts"=>[{"name"=>"Ahmed El Bayomi, MD", "role"=>"CONTACT", "email"=>"b.checked88@gmail.com", "phone"=>"01062702236", "phoneExt"=>"+2"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tanta University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Lecturer of Anesthesiology, Pain, and ICU Department", "investigatorFullName"=>"Ahmed B. Abo elkheer", "investigatorAffiliation"=>"Tanta University"}}}}
