[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643322":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":76,"collaborators":55,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":55,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":55,"enrollmentInfo":88,"targetDuration":55,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":102,"whyStopped":55,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Faisalabad Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (Ondansetron and Metoclopramide)- Separate syringes","EXPERIMENTAL","Participants receive\n\n* Ondansetron (4 mg IV) and\n* Metoclopramide (10 mg IV), in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.",[13,14],"Drug: ondansetron 4 mg","Drug: Metoclopramide 10mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B (Dexamethasone and Metoclopramide)- Separate syringes","ACTIVE_COMPARATOR","Participants receive\n\n* Dexamethasone 8mg IV and\n* Metoclopramide 10mg IV, in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.",[20,14],"Drug: Dexamethasone (intravenous)",[22,31,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","ondansetron 4 mg","Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.",[9],[28,29,30],"Zofran","Zophren","Onmax",{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Dexamethasone (intravenous)","Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.",[16],[36,37,38],"Decadron","Oradexon","Fortecortin",{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Metoclopramide 10mg","Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis. Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS \\>4 for nausea.",[9,16],[44,45,46],"Maxolon","Reglan","Paspertin",[48],{"name":49,"affiliation":5,"role":50},"Asifa Saeed, MBBS; FCPS","PRINCIPAL_INVESTIGATOR",[52,57],{"name":49,"role":53,"phone":54,"phoneExt":55,"email":56},"CONTACT","+923006694460",null,"drasifasaeed@gmail.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Huda Ather, MBBS","+923047922909","atherhudaather@gmail.com",[62],{"facility":5,"status":55,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":55,"geoPoint":55,"contacts":68},"Faisalābad","Punjab Province","38000","Pakistan","PK",[69,70,71,72,74],{"name":49,"role":53,"phone":54,"phoneExt":55,"email":56},{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},{"name":49,"role":50,"phone":55,"phoneExt":55,"email":55},{"name":58,"role":73,"phone":55,"phoneExt":55,"email":55},"SUB_INVESTIGATOR",{"name":75,"role":73,"phone":55,"phoneExt":55,"email":55},"M. Ibtisam Ahmad, MBBS",{"type":50,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Dr. Asifa Saeed","Head of Department Anaesthesiology and Critical Care, AHF-1","100643322","phase-4-time-to-first-rescue-antiemetic-with-ondansetron-plus-metoclopramide-versus-dexamethasone-plus-metoclopramide-for-ponv-prophylaxis-in-laparoscopic-cholecystectomy-100643322",false,"NCT07638527","Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy","Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Scheduled for elective laparoscopic cholecystectomy\n* Apfel score 2-4 (moderate to high risk for PONV)\n* Provides written informed consent prior to enrollment\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ondansetron, dexamethasone, or metoclopramide\n* Emergency surgery (e.g., acute cholecystitis, perforation, or gangrene)\n* Pregnancy or breastfeeding\n* ASA physical status III or IV\n* Preexisting hepatic impairment\n* Baseline corrected QT (QTc) interval \\> 420 ms on pre-operative ECG\n* History of dystonic reaction to metoclopramide or other dopamine antagonists\n* Preexisting renal impairment (e.g., serum creatinine \\> 1.5 mg\u002FdL or on dialysis)\n* Unable or unwilling to provide informed consent","ALL","18 Years",{"count":89,"type":90},264,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea\u002Fvomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery).\n\nThe main question this study aims to answer is:\n\n• Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide?\n\nResearchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication.\n\nParticipants will:\n\n* Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction.\n* Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea\n* Be monitored for 24 hours post-surgery in the hospital\n* Report nausea severity at 2, 6, 12 and 24 hours post-surgery",[96],"Postoperative Nausea and Vomiting",[98,99,100,101],"PONV","Postoperative emesis","Postoperative nausea","Postoperative vomiting","NOT_YET_RECRUITING","2026-06-09",{"date":105,"type":106},"2026-06-11","ACTUAL",{"date":108,"type":90},"2026-07",{"date":110,"type":90},"2027-04",{"name":5,"class":6},1]