[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643322":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":38,"armGroups":46,"interventions":60,"overallOfficials":86,"centralContacts":90,"locations":99,"responsibleParty":115,"collaborators":38,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":38,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":38,"enrollmentInfo":127,"targetDuration":38,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":101,"whyStopped":38,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Faisalabad Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Time to First Rescue Antiemetic (in minutes)","Time in minutes from patient arrival to Post-anaesthesia care unit, PACU (time zero) to administration of rescue metoclopramide 10 mg IV. Rescue is given if patient experiences any episode of vomiting\u002Fretching or reports a nausea Verbal Rating Scale (VRS) score \\>4. VRS scale is no nausea (0), mild (1-3), moderate (4-6), and severe (7-10).","First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Incidence of PONV","Proportion of patients experiencing any nausea (VRS \\>1) or any vomiting\u002Fretching episode within the first 24 hours post-surgery.\n\nVerbal Rating Scale (VRS) is a well established measurement scale with a total of 11 points where 0 = no nausea and 10 = worst possible nausea.","24 hours post-surgery",{"measure":19,"description":20,"timeFrame":21},"Severity of Postoperative Nausea and Vomiting (RINVR Score)","Measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). It evaluates 8 dimensions: frequency\u002Fduration\u002Fdistress of nausea; frequency\u002Famount\u002Fdistress of vomiting; and frequency\u002Fdistress of retching. Total score range is 0-32, with 0 indicating no nausea, 1-8 mild, 9-16 moderate, 17-24 severe, and 25-32 great nausea. The higher scores indicate worse PONV.","Measured at 2, 6, 12, and 24 hours post-surgery",{"measure":23,"description":24,"timeFrame":25},"Number of Rescue Doses Required","Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.","First 24 hours after surgery",{"measure":27,"description":28,"timeFrame":29},"Patient Satisfaction with Antiemetic Treatment","Patient-reported satisfaction measured on a 5-point Likert scale (Very Dissatisfied to Very Satisfied) at the end of hospital stay.\n\nLikert scale is a 5-point psychometric survey scale, with 1 indicating very disappointing and 5 indicating very satisfying. The higher the score, the better the treatment was.","At hospital discharge (approximately 24 hours post-surgery)",[31],{"measure":32,"description":33,"timeFrame":34},"Adverse Events","Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.","From drug administration up to 24 hours post-surgery",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":38,"timePerspective":38,"maskingInfo":40},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":41,"maskingDescription":38,"whoMasked":42},"TRIPLE",[43,44,45],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"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.",[52,53],"Drug: ondansetron 4 mg","Drug: Metoclopramide 10mg",{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59,53],"Drug: Dexamethasone (intravenous)",[61,70,78],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"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.",[48],[67,68,69],"Zofran","Zophren","Onmax",{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"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.",[55],[75,76,77],"Decadron","Oradexon","Fortecortin",{"type":62,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"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.",[48,55],[83,84,85],"Maxolon","Reglan","Paspertin",[87],{"name":88,"affiliation":5,"role":89},"Asifa Saeed, MBBS; FCPS","PRINCIPAL_INVESTIGATOR",[91,95],{"name":88,"role":92,"phone":93,"phoneExt":38,"email":94},"CONTACT","+923006694460","drasifasaeed@gmail.com",{"name":96,"role":92,"phone":97,"phoneExt":38,"email":98},"Huda Ather, MBBS","+923047922909","atherhudaather@gmail.com",[100],{"facility":5,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":38,"geoPoint":38,"contacts":107},"RECRUITING","Faisalābad","Punjab Province","38000","Pakistan","PK",[108,109,110,111,113],{"name":88,"role":92,"phone":93,"phoneExt":38,"email":94},{"name":96,"role":92,"phone":97,"phoneExt":38,"email":98},{"name":88,"role":89,"phone":38,"phoneExt":38,"email":38},{"name":96,"role":112,"phone":38,"phoneExt":38,"email":38},"SUB_INVESTIGATOR",{"name":114,"role":112,"phone":38,"phoneExt":38,"email":38},"M. Ibtisam Ahmad, MBBS",{"type":89,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"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":128,"type":129},264,"ESTIMATED","INTERVENTIONAL",[132],"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",[135],"Postoperative Nausea and Vomiting",[137,138,139,140],"PONV","Postoperative emesis","Postoperative nausea","Postoperative vomiting","2026-09-02",{"date":143,"type":144},"2026-09-04","ACTUAL",{"date":146,"type":129},"2026-09",{"date":148,"type":129},"2027-04",{"name":5,"class":6},1]