[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":71,"collaborators":47,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":47,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":47,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magnesium Sulfate","EXPERIMENTAL","10% magnesium sulfate intravenous bolus of 0.5 ml\u002Fkg (maximum 20 ml) over 5 min before induction of anesthesia followed by magnesium sulfate infusion at 0.15 ml\u002Fkg\u002Fh (maximum 6 ml\u002Fh) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.",[13],"Drug: Intravenous magnesium sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","0.9% NaCl (sodium chloride) intravenous bolus of 0.5 ml\u002Fkg (maximum 20 ml) over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml\u002Fkg\u002Fh (maximum 5ml\u002Fh) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.",[19],"Drug: Normal saline infusion",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravenous magnesium sulfate","Intraoperative intravenous magnesium sulfate infusion.",[9],[27],"IVM (intravenous magnesium)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Normal saline infusion","Intraoperative intravenous normal saline infusion.",[15],[33],"Placebo",[35],{"name":36,"affiliation":5,"role":37},"Izabela Pągowska-Klimek, prof.","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Alicja Kuczerowska, MD","CONTACT","601666694","+48","alicja.kuczerowska@uckwum.pl",{"name":46,"role":41,"phone":47,"phoneExt":47,"email":48},"Maciej Kaszyński, PhD",null,"maciej.kaszyński2@wum.edu.pl",[50],{"facility":51,"status":52,"city":53,"state":47,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Uniwersity Clinic Centre of Medical Uniwersity of Warsaw","RECRUITING","Warsaw","02-091","Poland","PL",{"type":58,"coordinates":59},"Point",[60,61],21.01178,52.22977,{"lat":61,"lon":60},[64,66,68,70],{"name":36,"role":41,"phone":47,"phoneExt":47,"email":65},"izabela.pagowska-klimek@wum.edu.pl",{"name":46,"role":67,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"name":36,"role":69,"phone":47,"phoneExt":47,"email":47},"SUB_INVESTIGATOR",{"name":40,"role":69,"phone":47,"phoneExt":47,"email":47},{"type":67,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Maciej Kaszyński","Principal Investigator","100559378","phase-4-magnesium-sulfate-in-children-undergoing-laparoscopic-appendectomy-100559378",false,"NCT06563349","Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy","The Effect of Intravenous Magnesium Infusion on the Opioid Consumption, the Circulatory, Metabolic and Hormonal Response to Intubation and Surgical Trauma During Anaesthesia for Laparoscopy in Children. Randomized Clinical Trial.","Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency)\n* Patients undergoing laparoscopic appendectomy\n\nExclusion Criteria:\n\n* Allergy to the magnesium sulfate or the excipient\n* Hypermagnesemia\n* Renal failure (GFR \\\u003C30 ml\u002Fmin)\n* Myasthenia gravis\n* Preoperative atrioventricular block\n* Hypotension\n* The use of digitalis glycosides\n* The use of oral anticoagulants\n* ASA physical status class 4E or higher\n* Chronic treatment with analgesics\n* Legal guardians or patient refusal","ALL","18 Months","18 Years",{"count":85,"type":86},188,"ESTIMATED","INTERVENTIONAL",[89],"PHASE4","Magnesium sulfate is one of the most commonly used co-analgetics. Its antinociceptive effect is related to antagonizing NMDA (N-methyl-D-aspartate) receptors of the nervous system, has an anti-inflammatory effect by reducing the concentration of IL-6 (interleukin 6) and tumor necrosis factor alpha. In adult patients, the need for morphine in the perioperative period is reduced when magnesium infusion is used. In current guidelines for treatment of acute pain in children, magnesium sulfate may be considered as a co-analgetic. However, the strength of such a recommendation is low due to the lack of reliable scientific research confirming the effectiveness of magnesium infusion in the pediatric population. The aim of this study is to evaluate the efficacy of intravenous magnesium sulfate infusion on the opioid consumption, the circulatory, metabolic and hormonal response to intubation and surgical trauma during anesthesia for laparoscopic appendectomy in children.",[92,93,94,95],"Opioid Consumption","Multimodal Analgesia","Acute Appendicitis","Complication of Treatment",[97,98,99,100,101,102,103,104,105],"multimodal analgesia","magnesium sulfate","laparoscopic appendectomy","children","pediatric population","adjuvant","metabolic stress response","hormonal response","inflammatory response","2024-11-09",{"date":108,"type":109},"2024-11-12","ACTUAL",{"date":111,"type":109},"2024-09-09",{"date":113,"type":86},"2027-10-01",{"name":5,"class":6},1]