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.
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.
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.
Parallel
Active taVNS Group
DeviceActive 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 / 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.
Sham stimulation group
DeviceThe 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.
The incidence of emergence delirium (ED)
Measurement Tools: Diagnosis will be made using the Pediatric Anesthesia Emergence Delirium (PAED) Scale (score range: 0-20, higher scores indicate worse delirium) and the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Scale (score range: 0-10, higher scores indicate worse pain). Diagnostic Criteria: 1. ED is defined as a PAED score ≥ 10 and a FLACC score \< 4. 2. If both PAED score ≥ 10 and FLACC score ≥ 4, the child will first receive intravenous fentanyl 0.5 μg·kg-¹ for analgesia. 3. Five minutes after analgesia, both scales will be reassessed. If the PAED score remains ≥ 10, the diagnosis of ED will be confirmed regardless of the FLACC score.
The incidence of postoperative pain
Defined as a FLACC score (Face, Legs, Activity, Cry, Consolability scale; score range 0-10, where higher scores indicate worse pain outcomes) of ≥ 4.
Quality of Recovery in Children (PedS-QoR Score)
Postoperative recovery quality will be assessed using the Pediatric Quality of Recovery Scale (PedS-QoR, 20-item version). This validated questionnaire evaluates children's physical comfort, emotional state, psychological well-being, and independence after surgery and anesthesia. Proxy Report: For children aged 2-7 years, completed by parents or caregivers. Self-Report: For children aged 8-17 years, completed by the child. The total score ranging from 20 to 100, where higher scores indicate better recovery quality.
Recovery Time
The time interval from the discontinuation of sevoflurane to the moment when the child is awakened and able to respond to their name spoken in a normal tone of voice, including cases where response is delayed due to emergence delirium (ED).
Adverse Events
All adverse events occurring during hospitalization will be recorded, including nausea, vomiting, pneumonia, and ta-VNS-related complications such as skin irritation, dizziness, or bradycardia.
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