[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623285":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active taVNS Group","EXPERIMENTAL","Participants in this group will receive active transcutaneous auricular vagus nerve stimulation (taVNS) during the perioperative period.\n\nStimulation will be applied to the left cymba conchae using an ear-clip electrode connected to a portable taVNS device.\n\nParameters: 25 Hz frequency, 300 µs pulse width, duty cycle 30 seconds ON \u002F 30 seconds OFF.\n\nThe stimulation starts before anesthesia induction and continues during surgery and recovery in the PACU.\n\nOn postoperative days 1 and 2, stimulation will be administered twice daily for 30 minutes each session.\n\nIntensity is adjusted until a mild tingling sensation is perceived without pain.",[13],"Device: Active taVNS Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Stimulation Group","SHAM_COMPARATOR","Participants receive sham stimulation applied to the left auricular concha. The device is applied in the same manner as the active group, but stimulation is inactive after initial titration. Stimulation schedule and duration are identical to the active group to maintain blinding",[19],"Device: Sham stimulation group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Active taVNS Group：The taVNS device delivers electrical stimulation via an ear-clip electrode placed on the left cymba conchae.Parameters: 25 Hz frequency, 300 µs pulse width, 30 s ON \u002F 30 s OFF duty cycle.Applied from pre-induction through postoperative recovery, then twice daily for 30 min on POD 1-2.Intensity adjusted to induce mild tingling without discomfort.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham stimulation group","The sham stimulation device is visually identical to the active taVNS unit. Electrodes are placed on the same auricular site, and procedures mimic active stimulation, but no electrical current is delivered.Used to maintain blinding and control for placebo effects.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Man Lu, M.Sc.","CONTACT","+8618368021733","18368021733@163.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)","Hangzhou","Zhejiang","310006","China","CN",{"type":45,"coordinates":46},"Point",[47,48],120.16142,30.29365,{"lat":48,"lon":47},[51,53],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":35},"Man Lu",{"name":54,"role":33,"phone":25,"phoneExt":25,"email":35},"Lu",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100623285","transcutaneous-auricular-vagus-nerve-stimulation-for-prevention-of-emergence-agitation-and-delirium-in-children-undergoing-tonsillectomy-and-adenoidectomy-100623285",false,"NCT07394647","Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy","Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Emergence Agitation and Delirium After Pediatric Tonsillectomy and Adenoidectomy: A Randomized, Double-Blind, Interventional Study","Inclusion Criteria:\n\n* Children aged 3 to 8 years.\n* Patients receiving care at The First Affiliated Hospital of Zhejiang Chinese Medical University with a diagnosis of tonsil and\u002For adenoid hypertrophy, scheduled for tonsillectomy and\u002For adenoidectomy under sevoflurane inhalation general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n* Ability to understand the study procedures and assessment scales, and to communicate effectively with study personnel.\n\nExclusion Criteria:\n\n* ASA physical status III-IV, or presence of hepatic or renal dysfunction, cardiovascular disease, or endocrine disorders.\n* Neuromuscular disorders or dermatitis of the left auricle.\n* Recent respiratory infection, developmental delay, or autism spectrum disorder.\n* Receipt of specialized care, residence in social welfare institutions, or any other condition that may interfere with study participation.\n* Current enrollment in another clinical trial.","ALL","3 Years","8 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"NA","Brief Summary This study is designed to find out whether transcutaneous auricular vagus nerve stimulation (taVNS) can safely reduce restlessness and confusion when children wake up from anesthesia after tonsillectomy and adenoidectomy. These problems, called emergence agitation and delirium, are common after surgery and can cause distress for both children and their families.TaVNS is a non-invasive treatment that delivers mild electrical stimulation to a specific area of the ear connected to the vagus nerve. It does not involve needles or medication, and children usually feel only a gentle tingling sensation.In this randomized, double-blind study, children will be assigned by chance to receive either taVNS or a sham (placebo) stimulation during surgery. Neither the children, their families, nor the medical team providing care will know which treatment each child receives.Researchers will observe and record how calmly children wake up from anesthesia, whether they show signs of delirium, and any side effects. The goal of this study is to test whether taVNS is an effective and safe way to improve recovery and comfort for children after surgery.",[75,76],"Emergence Agitation","Emergence Delirium",[78,75,76,79,80],"Pediatric","taVNS","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","NOT_YET_RECRUITING","2026-02-01",{"date":84,"type":85},"2026-02-06","ACTUAL",{"date":87,"type":69},"2026-02-24",{"date":89,"type":69},"2026-12-30",{"name":5,"class":6},1]