[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557651":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":39,"locations":50,"responsibleParty":84,"collaborators":44,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":44,"enrollmentInfo":98,"targetDuration":44,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Malaya","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Palonosetron Group (Group P)","EXPERIMENTAL","Group P will receive a stat dose of IV palonosetron 1.5mcg\u002Fkg diluted in a 5ml preparation of normal saline 0.9% prior to the commencement of general anaesthesia. At the start of wound closure, Group P will receive a 5ml preparation of normal saline 0.9% as a placebo.",[13],"Drug: Palonosetron (Group P)",{"label":15,"type":16,"description":17,"interventionNames":18},"Granisetron Group (Group G)","ACTIVE_COMPARATOR","Group G will receive a 5ml preparation of normal saline 0.9% as placebo prior to commencement of general anaesthesia. At the start of wound closure, a stat dose of IV granisetron 1mg in 5ml preparation will be administered.",[19],"Drug: Granisetron (Group G)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Palonosetron (Group P)","Group P will be receiving palonosetron 1.5mcg\u002Fkg before the commencement of general anaesthesia",[9],[27],"antiemetic",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Granisetron (Group G)","Group G participants will receive IV Granisetron 1mg at the start of wound closure",[15],[27],[34,37],{"name":35,"affiliation":5,"role":36},"Nantni Kumaran, MBBS","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":5,"role":36},"Mohd Shahnaz Hasan, MAnaes, MBBS",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Kenlee Liew, MBBS","CONTACT","+60195753579",null,"drkenliew@gmail.com",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Siti Nadzrah Yunus, MAnaes, MBBS","+60176975009","siti.nadzrah@ummc.edu.my",[51,73],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University Malaya","RECRUITING","Pantai Valley","Kuala Lumpur","59100","Malaysia","MY",{"type":60,"coordinates":61},"Point",[62,63],101.66667,3.11667,{"lat":63,"lon":62},[66,70],{"name":67,"role":42,"phone":68,"phoneExt":44,"email":69},"Siti Nadzrah Yunus, Postgrduate","60176975009","nadzrahyunus@gmail.com",{"name":71,"role":72,"phone":44,"phoneExt":44,"email":44},"Siti Nadzrah Yunus, Postgraduate","SUB_INVESTIGATOR",{"facility":74,"status":53,"city":55,"state":44,"zip":75,"country":57,"countryCode":58,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University Malaya Medical Centre","50603",{"type":60,"coordinates":77},[78,79],101.68653,3.1412,{"lat":79,"lon":78},[82],{"name":83,"role":42,"phone":44,"phoneExt":44,"email":44},"Nantni Kumaran, MD",{"type":36,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Dr. Siti Nadzrah Yunus","Doctor","100557651","phase-4-a-comparison-between-palonosetron-versus-granisetron-as-ponv-prophylaxis-in-scoliotic-patients-undergoing-spine-surgery-100557651",false,"NCT06540885","A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery","A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial","PONV","Inclusion Criteria:\n\n* Age: 10 years and above\n* American Society of Anesthesiologists (ASA) class I-II\n\nExclusion Criteria:\n\n* Active smoker\n* Obesity with body mass index (BMI) of 34 and above\n* Body weight of less than 30kg\n* History of gastro-esophageal reflux disease (GERD)\u002F other gastrointestinal diseases associated with vomiting\n* History of motion sickness\n* History of allergy to 5-HT3 (serotonin) receptor antagonists or dexamethasone\n* History of nausea or vomiting withing 24 hours before surgery\n* History of administration of antiemetics\u002F steroids\u002F psychoactive medications within 24 hours before the surgery\n* History of cardiac arrhythmias\n* Prolonged QT (QTc is prolonged if \\> 430ms in men or \\>450ms in women)",true,"ALL","10 Years",{"count":99,"type":100},74,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA).\n\nThe main questions the study aims to answer are:\n\nHow effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and\u002F or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.",[106,107],"Postoperative Nausea and Vomiting","Scoliosis",[109,110,111],"Antiemetics","Granisetron","Palonosetron","2025-04-22",{"date":114,"type":115},"2025-04-25","ACTUAL",{"date":117,"type":115},"2025-01-06",{"date":119,"type":100},"2026-09-30",{"name":5,"class":6},2]