[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658801":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":44,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":58,"collaborators":13,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":13,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":92,"whyStopped":13,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Clinically Significant Post-Spinal Shivering","Clinically significant shivering is defined as a shivering score \\>= 3 on the Crossley and Mahajan Shivering Grading Scale. The scale ranges from Grade 0 to Grade 4: Grade 0 = No shivering; Grade 1 = Piloerection or peripheral vasoconstriction without visible muscular activity; Grade 2 = Muscular activity confined to one muscle group; Grade 3 = Muscular activity involving more than one muscle group, but not generalized; Grade 4 = Gross muscular activity involving the whole body. Higher grades indicate greater shivering severity.","Up to 4 hours post-spinal injection",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,32,38],{"label":27,"type":28,"description":29,"interventionNames":30},"Group H: High-Dose Paracetamol (2 g)","EXPERIMENTAL","Patients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection.",[31],"Drug: Paracetamol 2 g",{"label":33,"type":34,"description":35,"interventionNames":36},"Group S: Standard-Dose Paracetamol (1 g)","ACTIVE_COMPARATOR","Patients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection.",[37],"Drug: Paracetamol 1 g",{"label":39,"type":40,"description":41,"interventionNames":42},"Group C: Placebo Control","PLACEBO_COMPARATOR","Patients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection.",[43],"Drug: Normal Saline Placebo",[45,50,54],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":13},"DRUG","Paracetamol 2 g","Intravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.",[27],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":13},"Paracetamol 1 g","Intravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.",[33],{"type":46,"name":55,"description":56,"armGroupLabels":57,"otherNames":13},"Normal Saline Placebo","Intravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding.",[39],{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Ahmed Osama Mohamed Mostafa","Resident","100658801","phase-4-optimizing-the-paracetamol-dose-for-prevention-of-post-spinal-shivering-in-lower-limb-orthopedic-surgeries-100658801",false,"NCT07855575","Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries","Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 65 years\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Scheduled for elective lower-limb orthopedic surgery under spinal anesthesia\n* Expected surgical duration between 1 and 3 hours\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Patient refusal or inability to provide informed consent\n* ASA physical status \\>= III\n* Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at injection site, severe spinal deformity)\n* Known allergy or hypersensitivity to paracetamol or the local anesthetic used\n* Baseline (preoperative) core\u002Ftympanic temperature \\\u003C 36.5°C or \\> 37.5°C\n* Pre-existing hepatic, renal, or thyroid disorders\n* History of seizure disorder\n* Chronic alcohol use, malnutrition, or any condition predisposing to hepatotoxicity\n* Body mass index (BMI) \\> 35 kg\u002Fm²\n* Pregnancy or lactation\n* Chronic use of antipyretic or anti-inflammatory medication within 24 hours of surgery\n* Cardiac arrhythmia or hemodynamic instability","ALL","18 Years","65 Years",{"count":73,"type":74},150,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo.\n\nAdult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups:\n\n* High-dose group: intravenous paracetamol 2 g\n* Standard-dose group: intravenous paracetamol 1 g\n* Control group: intravenous normal saline placebo\n\nEach infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.",[80,81,82],"Shivering","Postoperative Shivering","Hypothermia",[84,85,86,87,88,89,90,91],"Paracetamol","Acetaminophen","Spinal Anesthesia","Lower Extremity Surgery","Orthopedic Procedures","Dose-Response Relationship","Post-Spinal Shivering","Thermoregulation","NOT_YET_RECRUITING","2026-09-28",{"date":95,"type":96},"2026-10-02","ACTUAL",{"date":98,"type":74},"2026-11",{"date":100,"type":74},"2027-12",{"name":5,"class":6}]