[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659933":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":52,"collaborators":13,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":13,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":83,"whyStopped":13,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Pediatric Anesthesia Emergence Delirium (PAED) Scale Score","Evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale assesses 5 behavioral items: eye contact (0-4), purposeful actions (0-4), awareness of surroundings (0-4), restlessness (0-4), and consolability (0-4). Total scores range from 0 to 20, where higher scores indicate greater severity of emergence agitation\u002Fdelirium.","30 minutes after anesthesia discontinuation",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Group A: Nebulized Lidocaine","EXPERIMENTAL","Patients in this arm receive preoperative inhalation of 2% preservative-free lidocaine (2-4 mg\u002Fkg diluted to a total volume of 4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.",[31],"Drug: Lidocaine",{"label":33,"type":34,"description":35,"interventionNames":36},"Group B: Normal Saline Control","PLACEBO_COMPARATOR","Patients in this arm receive preoperative inhalation of an identical volume of 0.9% normal saline (4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.",[37],"Drug: 0.9% Normal Saline",[39,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Lidocaine","Preoperative administration of 2% preservative-free lidocaine at a dose of 2 to 4 mg\u002Fkg, diluted to a total volume of 4 mL, delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.",[27],[45,46,47],"Lignocaine","2% Preservative-Free Lidocaine","Nebulized Lidocaine",{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":13},"0.9% Normal Saline","Preoperative administration of an identical volume of 4 mL of 0.9% normal saline delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.",[33],{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Seif Eldien AbdElbaset Abd Allah Khalil","Resident","100659933","phase-3-effect-of-nebulized-lignocaine-on-emergence-agitation-after-sevoflurane-anesthesia-in-pediatric-patients-undergoing-tonsillectomy-100659933",false,"NCT07871266","Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy","Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy: A Randomized Controlled Double-Blinded Clinical Trial","Inclusion Criteria:\n\n* Pediatric patients scheduled for elective tonsillectomy operation\n* Patients below 9 years of age\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Written informed consent provided by a parent or legal guardian\n\nExclusion Criteria:\n\n* Emergency surgical cases, including patients presenting with active tonsillar bleeding\n* American Society of Anesthesiologists (ASA) physical status III or IV\n* Known hypersensitivity or allergy to lidocaine, amide local anesthetics, or sevoflurane\n* Pre-existing upper airway obstruction, active lower respiratory tract infection, or severe reactive airway disease\n* Significant hepatic, renal, cardiac, or neurological disorders","ALL","3 Years","9 Years",{"count":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and irritation in the upper airway. The primary aim of this clinical trial is to evaluate whether preoperative administration of nebulized lidocaine reduces the incidence and severity of emergence agitation compared to normal saline in pediatric patients undergoing elective tonsillectomy under sevoflurane anesthesia.\n\nParticipants are randomly allocated into two study groups in a 1:1 ratio:\n\n* Group A (Lidocaine Group): Receives preoperative inhalation of 2% preservative-free lidocaine (2-4 mg\u002Fkg diluted to 4 mL) administered via a nebulizer.\n* Group B (Control Group): Receives preoperative inhalation of an identical volume (4 mL) of 0.9% normal saline placebo via a nebulizer.\n\nBoth groups receive a standardized sevoflurane-based general anesthetic. Emergence agitation is evaluated during the first 30 minutes following anesthesia cessation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes evaluate postoperative pain severity (FLACC scale), rescue analgesic and sedative requirements, time to extubation, PACU length of stay, and airway-related or systemic complications.",[74,75,76],"Emergence Agitation","Emergence Delirium","Postoperative Pain",[47,45,78,79,80,81,82],"Sevoflurane","Pediatric Anesthesia","Tonsillectomy","Pediatric Anesthesia Emergence Delirium (PAED)","Airway Hyperreactivity","NOT_YET_RECRUITING","2026-10-07",{"date":86,"type":87},"2026-10-13","ACTUAL",{"date":89,"type":68},"2026-11",{"date":91,"type":68},"2027-12",{"name":5,"class":6}]