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Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation for the Prevention of Emergence Delirium in Children: A Prospective Randomized Controlled Study

Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation for the Prevention of Emergence Delirium in Children: A Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108258
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium,ED

Interventions

TaVNS Group:The main stimulation areas were the distribution areas of the vagus nerve in the concha cavity (auricular heart and kidney) (see Figure 1). The individualized current intensity determined
Control Group:Transcutaneous auricular electrical vagus nerve stimulation was used in both ears for 30 minutes. The main stimulation area was the scaphoid part of the upper ear at the midpoint of the

Sponsors

Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 6 to 18 years old; 2. Children under general anesthesia; 3. ASA Class I or II; 4. No history of ulceration, serious diseases and surgery on the skin of both ears; 5. Passed the taVNS tolerance test in the awake state before surgery;

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary disease, neurological disease, or psychiatric disease, 2. Those with immune system diseases and coagulation dysfunction; 3. Other sedative and analgesic drugs before surgery; 4. The operation lasts less than half an hour; 5. Refusal to sign the informed consent form; 6. Those who participate in other clinical trials at the same time;

Design outcomes

Primary

MeasureTime frame
Incidence rate of emergence delirium;

Secondary

MeasureTime frame
Incidence rate of additional sedation;Intraoperative maintenance drug dosage;Incidence rate of additional postoperative analgesics;Intraoperative heart rate and blood pressure;FLACC;recovery time;PHBQ score on the 7th day after surgery;

Countries

China

Contacts

Public ContactLijing Li

Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health

amber1717@163.com+86 189 1055 0202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026