Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Deliri… (NCT07394647) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy
China120 participantsStarted 2026-02-24
Plain-language summary
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.
Who can participate
Age range
3 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 3 to 8 years.
* Patients receiving care at The First Affiliated Hospital of Zhejiang Chinese Medical University with a diagnosis of tonsil and/or adenoid hypertrophy, scheduled for tonsillectomy and/or adenoidectomy under sevoflurane inhalation general anesthesia.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Ability to understand the study procedures and assessment scales, and to communicate effectively with study personnel.
Exclusion Criteria:
* ASA physical status III-IV, or presence of hepatic or renal dysfunction, cardiovascular disease, or endocrine disorders.
* Neuromuscular disorders or dermatitis of the left auricle.
* Recent respiratory infection, developmental delay, or autism spectrum disorder.
* Receipt of specialized care, residence in social welfare institutions, or any other condition that may interfere with study participation.
* Current enrollment in another clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of emergence delirium (ED)
Timeframe: Every 10 min during after the patient removed the endotracheal tube ，in the first 30 min in the Post-Anesthesia Care Unit (PACU).
Trial details
NCT IDNCT07394647
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University