Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy

Starting soon · Not applicable · Has a placebo group

Conditions studied: Emergence Agitation, Emergence Delirium

In brief

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.

Key facts

Study ID

NCT07394647

Run by

The First Affiliated Hospital of Zhejiang Chinese Medical University

People needed

120

Starts

2026-02-24

Expected to finish

2026-12-30

Last updated by the study team

2026-02-06

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine) — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.