Nctid:
NCT06233032
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000004809", "term"=>"Ephedrine"}, {"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"}, {"id"=>"D000000697", "term"=>"Central Nervous System Stimulants"}, {"id"=>"D000013566", "term"=>"Sympathomimetics"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000014662", "term"=>"Vasoconstrictor Agents"}], "browseLeaves"=>[{"id"=>"M22662", "name"=>"Dexmedetomidine", "asFound"=>"Human", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M7966", "name"=>"Ephedrine", "asFound"=>"Immune Checkpoint Inhibitors", "relevance"=>"HIGH"}, {"id"=>"M27586", "name"=>"Pseudoephedrine", "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"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}, {"id"=>"M16345", "name"=>"Sympathomimetics", "relevance"=>"LOW"}, {"id"=>"M17409", "name"=>"Vasoconstrictor Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["CARE_PROVIDER"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-06", "completionDateStruct"=>{"date"=>"2025-09-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2023-09-05", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-07-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale", "timeFrame"=>"45min", "description"=>"one hundred Pts will be included in this study .\n\n1. fifty patients will receive Ephedrine 6 mg IV bolus before spinal block.\n2. fifty patients will be receive 30 microgram IV bolus before spinal block"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Prevention of Shivering With Spinal Anaesthesia"]}, "descriptionModule"=>{"briefSummary"=>"Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia", "detailedDescription"=>"Shivering, rhythmic oscillatory movement of upper limbs, neck and jaw, is common during regional anesthesia with an incidence up to 56.7% of patients. Perioperative shivering is a commonly observed clinical problem well known to anesthesiologists caring for women undergoing a Cesarean delivery (CD). The median incidence of shivering in parturients having labour epidural analgesia or CD with epidural or spinal anesthesia has been estimated to be 52%.1 Severe shivering causes physiologic stress, interferes with patient monitors, and decreases the comfort and overall satisfaction of women during childbirth. Ephedrine well-known sympathomimetic agent, has been used to treat hypotension during regional anesthesia. It has antiemetic effect for short-term . Ephedrine maintained hemodynamics and minimized decrease of the core temperature when given by an intravenous infusion during spine surgery under general anesthesia . Dexmedetomidine, a selective a-2 agonist, was introduced in clinical practice in the United States in 1999. It is approved by Health Canada as a short-term sedative for mechanically ventilated adult patients in the intensive care unit and sedation of non-intubated patients prior to and/or during surgical procedures. It has since been approved and is widely used in pediatric populations and for procedural sedation of non-intubated patients.9 Nevertheless, the clinical use of dexmedetomidine has expanded to various off-label uses. In obstetrical anesthesia, it has been used as part of multi-modal intravenous labour and post-CD analgesia,10-13 as a neuraxial adjunct in the epidural space for labour,14 and intrathecally for shivering prevention during CD"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult female from 18 to 35 yrs\n* uncomplicated pregnancy for elective cesarean delivery\n\nExclusion Criteria:\n\n* patient refusal\n* allergy to the drug\n* contraindications of spinal anaesthesia\n* patients with DM or thyroid disorders"}, "identificationModule"=>{"nctId"=>"NCT06233032", "briefTitle"=>"Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"Could Ephedrine Replace Dexmedetomidine for Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia", "orgStudyIdInfo"=>{"id"=>"Prevention of shivering"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group E", "interventionNames"=>["Drug: Ephedrine"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group D", "interventionNames"=>["Drug: Dexmedetomidine"]}], "interventions"=>[{"name"=>"Ephedrine", "type"=>"DRUG", "description"=>"Patient Will receive 6mg IV", "armGroupLabels"=>["Group E"]}, {"name"=>"Dexmedetomidine", "type"=>"DRUG", "description"=>"Patient Will receive 30mcg IV", "armGroupLabels"=>["Group D"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Assiut", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Assiut university", "role"=>"CONTACT", "email"=>"Vp_grad@aun.edu.eg", "phone"=>"+209922080150"}], "facility"=>"Assiut university", "geoPoint"=>{"lat"=>27.18096, "lon"=>31.18368}}], "centralContacts"=>[{"name"=>"Dina Salah Kamal, Master", "role"=>"CONTACT", "email"=>"dina14296@gmail.com", "phone"=>"01009196736"}, {"name"=>"Ola Mahmoud, Professor", "role"=>"CONTACT", "phone"=>"01013046017"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal investigator", "investigatorFullName"=>"Dina Salah Kamal Salman", "investigatorAffiliation"=>"Assiut University"}}}}
