[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Faisalabad Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"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":19,"type":20},264,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Postoperative Nausea and Vomiting",[28,29,30,31],"PONV","Postoperative emesis","Postoperative nausea","Postoperative vomiting","NOT_YET_RECRUITING","2026-06-09",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":20},"2026-07",{"date":40,"type":20},"2027-04",{"name":42,"class":43},"Faisalabad Medical University","OTHER",""]