[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658690":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":22,"interventions":34,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":44,"collaborators":13,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":13,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":13,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":74,"whyStopped":13,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Post-Spinal Shivering Score","Post-spinal shivering severity is assessed using a 5-point shivering scale where Grade 0 indicates no shivering; Grade 1 indicates piloerection or peripheral vasoconstriction without visible shivering; Grade 2 indicates muscular activity in only one muscle group; Grade 3 indicates muscular activity in more than one muscle group, but not generalized; and Grade 4 indicates generalized, whole-body shivering. Total scores range from 0 to 4, with higher scores representing greater shivering severity","Up to 2 hours postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"PARTICIPANT",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Group P: Paracetamol Group","ACTIVE_COMPARATOR","Participants receive intravenous paracetamol at a dose of 15 mg\u002Fkg infused over 15 minutes immediately after the completion of the subarachnoid block.",[28],"Drug: Paracetamol",{"label":30,"type":25,"description":31,"interventionNames":32},"Group M: Magnesium Sulfate Group","Participants receive intravenous magnesium sulfate at a dose of 30 mg\u002Fkg administered immediately after the completion of the subarachnoid block.",[33],"Drug: Magnesium Sulfate",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":13},"DRUG","Paracetamol","Administered intravenously at a dose of 15 mg\u002Fkg infused over 15 minutes immediately after the completion of the subarachnoid block.",[24],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"Magnesium Sulfate","Administered intravenously at a dose of 30 mg\u002Fkg immediately after the completion of the subarachnoid block.",[30],{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Maram Ahmed Gad Abozaid","Resident","100658690","phase-4-intravenous-paracetamol-versus-magnesium-sulfate-for-control-of-shivering-following-spinal-anesthesia-in-cesarean-section-100658690",false,"NCT07855588","Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section","Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section: A Comparative Study","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status class I or II\n* Pregnant women aged 20 to 40 years\n* Term gestation (\\>= 37 weeks) with an uncomplicated pregnancy\n* Scheduled for elective cesarean delivery under planned spinal anesthesia\n* Patient agreement and signed written informed consent\n\nExclusion Criteria:\n\n* Patient refusal\n* Morbid obesity (BMI \\> 35 kg\u002Fm²)\n* Contraindications to spinal anesthesia\n* Significant organ dysfunction (e.g., cardiac, respiratory, renal, or hepatic disorders)\n* Known hypersensitivity or allergy to paracetamol or magnesium sulfate\n* Cardiovascular or neuromuscular disorders in which magnesium administration is contraindicated\n* Emergency cesarean section","FEMALE","20 Years","40 Years",{"count":59,"type":60},90,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","Spinal anesthesia is widely used for cesarean deliveries, but shivering is a frequent complication that occurs in 40% to 60% of patients. Post-spinal shivering can cause maternal discomfort, increase oxygen consumption and metabolic demands, and interfere with clinical monitoring. Both paracetamol and magnesium sulfate have thermoregulatory properties that may prevent or reduce shivering.\n\nThe purpose of this clinical trial is to compare the efficacy and safety of intravenous paracetamol versus intravenous magnesium sulfate in preventing and reducing shivering following spinal anesthesia in women undergoing elective cesarean section.\n\nA total of 90 pregnant women scheduled for elective cesarean delivery will be randomly assigned to one of two groups:\n\n* Group P (Paracetamol Group): Participants receive intravenous paracetamol (15 mg\u002Fkg) infused over 15 minutes immediately following the subarachnoid block.\n* Group M (Magnesium Sulfate Group): Participants receive intravenous magnesium sulfate (30 mg\u002Fkg) administered immediately following the subarachnoid block.\n\nThe primary outcome evaluated is the severity of post-spinal shivering assessed by shivering scores. Secondary outcomes include hemodynamic parameters (heart rate, blood pressure, oxygen saturation), postoperative pain, complications such as nausea and vomiting, and maternal satisfaction.",[66,67],"Shivering","Post-Spinal Shivering",[37,69,41,70,71,72,73],"Acetaminophen","Spinal Anesthesia","Cesarean Section","Subarachnoid Block","Thermoregulation","NOT_YET_RECRUITING","2026-09-28",{"date":77,"type":78},"2026-10-02","ACTUAL",{"date":80,"type":60},"2026-11",{"date":82,"type":60},"2027-12",{"name":5,"class":6}]