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Efficacy and Safety of Low-Concentration Sevoflurane Inhalation Combined with Transcutaneous Auricular Vagus Nerve Stimulation for Social Impairment in Children with Autism Spectrum Disorder: A Prospective, Single-Arm Clinical Study

Efficacy and Safety of Low-Concentration Sevoflurane Inhalation Combined with Transcutaneous Auricular Vagus Nerve Stimulation for Social Impairment in Children with Autism Spectrum Disorder: A Prospective, Single-Arm Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119672
Enrollment
Unknown
Registered
2026-03-02
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Autism Spectrum Disorder

Interventions

Intervention group:On the basis of original routine care (including but not limited to behavioral intervention therapy and social skills training), children will receive additional intervention with s

Sponsors

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. Aged 3 to 18 years, with no gender restrictions; 3. Subjects are capable of completing all required tests and assessments; 4. Parents or legal guardians possess sufficient reading and comprehension skills to cooperate with the completion of relevant assessment scales and follow-up evaluations; 5. Parents or legal guardians provide written informed consent and participate in the study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Susceptibility to malignant hyperthermia: individuals with a family history or confirmed diagnosis of malignant hyperthermia; known carriers of pathogenic mutations in RYR1, CACNA1S, or other related genes; a history of severe adverse reactions (e.g., unexplained hyperthermia, muscle rigidity, rhabdomyolysis) following previous inhalation anesthesia; 2. Active neurological diseases: frequent or poorly controlled epilepsy; a history of central nervous system disorders such as intracranial infection, space-occupying lesion, or intracranial hypertension. 3. Severe respiratory or circulatory diseases: unrepaired congenital heart disease or poor surgical outcome; chronic pulmonary disease, poorly controlled asthma, respiratory insufficiency, etc; 4. Severe electrolyte imbalance, abnormal hepatic or renal function, or metabolic disorders; 5. Use of monoamine oxidase inhibitor (MAOI) antidepressants within 2 weeks before the study; 6. Use of antipsychotic medications such as risperidone within 3 months before the study; 7. Participation in another clinical trial within 30 days before study initiation and/or during the current study.

Design outcomes

Primary

MeasureTime frame
Aberrant Behavior Checklist-Social Withdrawal subscale;

Secondary

MeasureTime frame
Aberrant Behavior Checklist-Irritability subscale;Clinical Global Impression Scale;

Countries

China

Contacts

Public ContactXiaoping Gu

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

xgu1180@vip.163.com+86 138 1399 6903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026