[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-spinal-shivering\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-spinal-shivering":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,74,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"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":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Shivering","Post-Spinal Shivering",[30,31,32,33,34,35,36],"Paracetamol","Acetaminophen","Magnesium Sulfate","Spinal Anesthesia","Cesarean Section","Subarachnoid Block","Thermoregulation","NOT_YET_RECRUITING","2026-09-28",{"date":40,"type":41},"2026-10-02","ACTUAL",{"date":43,"type":21},"2026-11",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"Assiut University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":73,"locationsCount":4},"100658620","phase-4-efficacy-of-intravenous-midazolam-ketamine-combination-versus-placebo-for-prevention-of-post-spinal-shivering-in-elective-cesarean-section-100658620","NCT07855523","Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section","Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged 18 to 40 years old.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Singleton pregnancy.\n* Term pregnancy (37 to 41 weeks of gestation).\n* Scheduled for elective cesarean section under spinal anesthesia.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Body mass index (BMI) ≥ 40 kg\u002Fm².\n* Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at the puncture site).\n* Known hypersensitivity or allergy to midazolam or ketamine.\n* Pre-existing hypertension, pre-eclampsia, or cardiovascular disease.\n* Severe cardiovascular, renal, or hepatic dysfunction.\n* Neurological or psychiatric disorders (including epilepsy or history of psychosis).\n* Baseline (preoperative) body temperature \\\u003C 36°C or \\> 37.5°C.\n* Chronic use of sedatives, opioids, or medications affecting thermoregulation.","18 Years",{"count":58,"type":21},120,[24],"Spinal anesthesia is the preferred anesthetic method for elective cesarean deliveries, but it frequently causes post-spinal shivering. Shivering causes marked maternal discomfort, interferes with clinical monitoring, and increases oxygen consumption and metabolic workload.\n\nThis study aims to assess whether a prophylactic intravenous combination of low-dose midazolam and low-dose ketamine reduces the occurrence and severity of shivering compared with a placebo in women undergoing elective cesarean delivery under spinal anesthesia.\n\nA total of 120 parturients will be randomly assigned into two equal groups:\n\n* Combination Group: Receives intravenous midazolam (0.0375 mg\u002Fkg) combined with ketamine (0.25 mg\u002Fkg) diluted in 20 mL of 0.9% normal saline.\n* Control Group: Receives 20 mL of 0.9% normal saline intravenously as a placebo.\n\nIn both groups, the intravenous infusion is administered over 10 minutes immediately following delivery of the infant and clamping of the umbilical cord, ensuring no transplacental transfer of the study medications to the newborn.\n\nThe primary objective is to evaluate the proportion of patients who develop shivering during the first 60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary objectives include shivering severity, the requirement for rescue anti-shivering medication, intraoperative and postoperative sedation levels, hemodynamic stability, body temperature course, potential medication side effects, and maternal satisfaction.",[27,28,62,34],"Hypothermia",[64,65,33,66,67,68,69],"Midazolam","Ketamine","Cesarean Delivery","Postanesthetic Shivering","Crossley and Mahajan Scale","Ramsay Sedation Scale",{"date":40,"type":41},{"date":43,"type":21},{"date":45,"type":21},{"name":47,"class":48},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":56,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100618150","phase-3-comparative-dose-response-of-intrathecal-dexmedetomidine-for-post-spinal-shivering-100618150","NCT07327879","Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering","Comparative Efficacy and Dose-Response of Intrathecal Dexmedetomidine in Attenuating Post-Spinal Shivering: Double-Blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients (age 18-75 years)\n* Scheduled for ureteric stone removal surgery\n* ASA(American Society of Anesthesiologists) physical status I, II, or III\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Known allergy to dexmedetomidine, bupivacaine, or other study medications\n* Preexisting bradycardia (heart rate \\\u003C50 beats per minute)\n* Second- or third-degree atrioventricular (AV) block without a pacemaker\n* Severe hepatic dysfunction\n* Uncontrolled hypotension\n* Pregnancy\n* Chronic use of α₂-agonists or antagonists (e.g., clonidine, tizanidine)\n* Infection at the planned spinal puncture site\n* Coagulopathy or bleeding disorder\n* Inability to rate or communicate shivering (e.g., language barrier, cognitive impairment)","ALL","75 Years",{"count":58,"type":21},[85],"PHASE3","Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory\u002Fmotor block and may blunt thermoregulatory shivering mechanisms. Several randomized controlled trials and meta-analyses have demonstrated decreased shivering incidence with intrathecal dexmedetomidine, but reported doses vary (commonly 2.5, 5, and 10 µg, and in some trials up to 15-20 µg), and the balance between efficacy and adverse effects (sedation, bradycardia, and hypotension) is not fully established. Hence, a head-to-head randomized comparison of several low-to-moderate intrathecal doses is warranted.\n\nObjective: to compare the safety and efficacy of three intrathecal dexmedetomidine doses (2.5 µg, 5 µg, 10 µg) versus placebo for the prevention of post-spinal shivering.",[28],[89],"Intrathecal Dexmedetomidine","2025-12-26",{"date":92,"type":41},"2026-01-08",{"date":94,"type":21},"2026-01-28",{"date":96,"type":21},"2026-12-30",{"name":98,"class":48},"Al-Azhar University",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":81,"minAge":56,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100599754","phase-4-efficacy-of-oral-ondansetron-strips-on-prevention-of-post-spinal-shivering-100599754","NCT07088601","Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering","Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering; a Double Blinded, Randomized Controlled Study","OOPS","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I, II.\n* Patients underwent elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Morbid obese patients or those who were not candidates for spinal anesthesia.\n* Pregnant females.\n* Patients with comorbidities such as severe cardiopulmonary, severe hepatic or renal diseases, thyroid disorders, and convulsions.\n* Uncooperative patients and patients with psychological disorders.\n* Patients on regular ondansetron or other antiemetics.\n* Patients taking selective serotonin reuptake inhibitors.\n* Patients with allergy to 5-HT3 receptor antagonist drugs.\n* Patients receiving saddle spinal block.\n* In surgeries less than 1 h or longer than 3 hours duration.","65 Years",{"count":110,"type":21},50,[24],"This study aims to investigate the efficacy of oral ondansetron film strips on the incidence of post-spinal shivering in patients undergoing surgeries using spinal anesthesia at Kasr Alainy hospitals, Cairo University.\n\nThis prospective, double-blinded, randomized controlled study will be conducted on 50 patients aged from 18 to 65 years of both sexes with ASA I, II who are scheduled for elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries. Patients will be divided into two equal groups: Group (O) will receive oral ondansetron in the form of an oral soluble film 4 mg strip immediately before insertion of IV cannula and group (C) will receive a placebo in the form of an oral peppermint strip immediately before insertion of the IV cannula.",[28],"2025-07-27",{"date":116,"type":41},"2025-07-30",{"date":118,"type":21},"2025-08-10",{"date":120,"type":21},"2025-12-29",{"name":122,"class":48},"Cairo University","Post Spinal Shivering"]