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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Active taVNS Group
  • Sham stimulation group

Treatment groups

120 Participants
are divided into 2 treatment groups