[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653310":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":34,"interventions":47,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":25},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Episodes of Moderate-to-Severe Postoperative Nausea and Vomiting Requiring Rescue Antiemetics","The number of episodes of moderate-to-severe postoperative nausea and vomiting requiring rescue antiemetic medication within 3 days after surgery.","Within 72 hours after surgery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Quality of Recovery (QoR-15K) Score","Quality of recovery assessed using the Korean version of the 15-item Quality of Recovery questionnaire (QoR-15K) before surgery and on postoperative days 1, 2, and 3. The QoR-15K score ranges from 0 to 150, with higher scores indicating better recovery.","Preoperatively and on postoperative days 1, 2, and 3",{"measure":19,"description":20,"timeFrame":21},"Postoperative Nausea and Vomiting Severity","Severity of postoperative nausea and vomiting assessed at 24, 48, and 72 hours after surgery using a 4-point scale (0: none, 1: mild, 2: moderate, 3: severe).","24, 48, and 72 hours after surgery",{"measure":23,"description":24,"timeFrame":21},"Postoperative Pain Score","Postoperative pain assessed at 24, 48, and 72 hours after surgery using the 11-point Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":31,"maskingDescription":25,"whoMasked":32},"SINGLE",[33],"OUTCOMES_ASSESSOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Control group","ACTIVE_COMPARATOR","Patients receive inhalational anesthesia with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.",[40],"Other: Standard antiemetic and anesthetic protocol",{"label":42,"type":43,"description":44,"interventionNames":45},"Multimodal group","EXPERIMENTAL","After anesthesia induction, an ultrasound-guided superficial cervical plexus block is performed using 10 mL of 0.75% ropivacaine on the surgical side of the neck. Total intravenous anesthesia with propofol and remifentanil is used for maintenance. Dexamethasone 5 mg, palonosetron 0.075 mg, and acetaminophen 1 g are administered intravenously 1 hour before the end of surgery.",[46],"Other: Multimodal antiemetic and anesthetic protocol",[48,52],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":25},"Standard antiemetic and anesthetic protocol","Patients receive general anesthesia maintained with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.",[36],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":25},"Multimodal antiemetic and anesthetic protocol","The multimodal protocol consists of total intravenous anesthesia with propofol and remifentanil, ultrasound-guided superficial cervical plexus block with 10 mL of 0.75% ropivacaine, and intravenous administration of dexamethasone 5 mg, palonosetron 0.075 mg, and acetaminophen 1 g 1 hour before the end of surgery.",[42],{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Shin Kyung Won, MD","Clinical Assistant Professor","100653310","effect-of-a-multimodal-antiemetic-protocol-on-postoperative-nausea-and-vomiting-in-patients-undergoing-flap-surgery-for-head-and-neck-cancer-100653310",false,"NCT07786155","Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer","Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 19 years or older undergoing elective flap surgery for head and neck cancer\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the study\n* Patients undergoing emergency surgery\n* Patients with signs of inflammation (such as erythema) at the nerve block injection site\n* Patients with a history of hypersensitivity or adverse reactions to ropivacaine\n* Patients with difficulty completing questionnaires due to conditions such as dementia or delirium\n* Patients with severe cardiopulmonary disease\n* Patients with QT prolongation on preoperative ECG Patients deemed unsuitable for participation by the investigator","ALL","19 Years",{"count":70,"type":71},72,"ESTIMATED","INTERVENTIONAL",[74],"NA","This prospective randomized controlled trial evaluates whether a multimodal antiemetic protocol can reduce postoperative nausea and vomiting (PONV) in patients undergoing flap surgery for head and neck cancer. Seventy-two patients will be randomized to receive either standard dexamethasone-based prophylaxis or a multimodal protocol incorporating TIVA, superficial cervical plexus block, palonosetron, dexamethasone, and acetaminophen. PONV, postoperative pain, quality of recovery, and other postoperative outcomes will be compared.",[77],"Postoperative Nausea and Vomiting","NOT_YET_RECRUITING","2026-08-24",{"date":81,"type":82},"2026-08-26","ACTUAL",{"date":84,"type":71},"2026-09-01",{"date":86,"type":71},"2029-09-01",{"name":5,"class":6}]