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

NCT07394647 | Not Yet Recruiting

• 1 other identifier: MR-33-25-067114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergence Agitation; Emergence Delirium

Keywords

Pediatric; Emergence Agitation; Emergence Delirium; taVNS; Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 10 min during after the patient removed the endotracheal tube ，in the first 30 min in the Post-Anesthesia Care Unit (PACU).

Secondary Outcomes (4)

• The incidence of postoperative pain

  Assessed at 0, 5, 10, 20, and 30 minutes after emergence from anesthesia.

• Quality of Recovery in Children (PedS-QoR Score)

  Assessed at 24 and 48 hours after surgery.

• Recovery Time

  Recovery parameters were assessed every 5 min in the first 30 min after anesthesia discontinuation and then every 10 min until discharge criteria were met or up to 120 min.

• Adverse Events

  From initiation of the intervention through 3 days after surgery.

Study Arms (2)

Active taVNS Group

EXPERIMENTAL

Participants in this group will receive active transcutaneous auricular vagus nerve stimulation (taVNS) during the perioperative period. Stimulation will be applied to the left cymba conchae using an ear-clip electrode connected to a portable taVNS device. Parameters: 25 Hz frequency, 300 µs pulse width, duty cycle 30 seconds ON / 30 seconds OFF. The stimulation starts before anesthesia induction and continues during surgery and recovery in the PACU. On postoperative days 1 and 2, stimulation will be administered twice daily for 30 minutes each session. Intensity is adjusted until a mild tingling sensation is perceived without pain.

Device: Active taVNS Group

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

Device: Sham stimulation group

Interventions

Active taVNS Group 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 / 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.

Active taVNS Group

Sham stimulation group DEVICE

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.

Sham Stimulation Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Hangzhou, Zhejiang, 310006, China

Location

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Related Links

• The First Affiliated Hospital of Zhejiang Chinese Medical University official site

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Man Lu, M.Sc.

CONTACT

+8618368021733; 18368021733@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the active transcutaneous auricular vagus nerve stimulation (taVNS) group or the sham stimulation group. Both participants and study personnel involved in intervention delivery and outcome assessment are blinded to group allocation. The effects of taVNS on emergence agitation and emergence delirium after pediatric tonsillectomy and adenoidectomy will be compared between the two parallel groups.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: February 6, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Supporting information (study protocol and statistical analysis plan) will be available beginning 6 months after study completion and for up to 3 years following publication of the primary results.
• Access Criteria: Access to the study protocol and statistical analysis plan will be granted to academic researchers affiliated with recognized institutions for non-commercial research purposes. Requests should be submitted to the principal investigator by email. Data sharing will require prior approval and signing of a data use agreement.

Locations

CN (1)