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An Open-label, Single-arm, Multicenter Study of the Efficacy and Safety of Low-Concentration Sevoflurane in Patients with Autism Spectrum Disorder

An Open-label, Single-arm, Multicenter Study of the Efficacy and Safety of Low-Concentration Sevoflurane in Patients with Autism Spectrum Disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110832
Enrollment
Unknown
Registered
2025-10-21
Start date
2024-10-08
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Autism Spectrum Disorder

Interventions

Sponsors

Guangzhou Medical University Affiliated Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for Autism Spectrum Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 2. Age between 3 and 18 years, right-handed, gender not limited; 3. Capable of completing all assessments; 4. The participant's parent or legal guardian has good reading and comprehension skills and is able to cooperate in completing the filling out of relevant assessment scales and follow-ups; 5. The participant's parent or legal guardian has provided written informed consent, voluntarily participating in this study.

Exclusion criteria

Exclusion criteria: 1. Other psychiatric disorders besides Autism Spectrum Disorder (such as epilepsy, schizophrenia, attention deficit hyperactivity disorder, intellectual disability, cerebral ischemia and hypoxia, encephalitis, history of head injury, poisoning, etc.); 2. Severe physical illnesses or other systemic diseases (history of kidney, liver, metabolic deficiency, tumors, infections, organic neurological diseases, endocrine or immune diseases, etc.); 3. Serum K+ or Mg2+ levels outside the normal range; 4. History of malignant syndrome or tardive dyskinesia; 5. Use of monoamine oxidase inhibitors within 2 weeks prior to the study; 6. Have taken antipsychotic drugs such as risperidone in the three months prior to the study; 7. Participation in other studies within 30 days prior to the start of the current study and/or during the study period.

Design outcomes

Primary

MeasureTime frame
Childhood Autism Rating Scale;

Secondary

MeasureTime frame
Autism Treatment Evaluation Checklis;Autism Behavior Checklist;Clinical Global Impression-Severity;Clinical Global Impression-Improvement;Wechsler Intelligence Scale for Children;Electroencephalogram;Functional Magnetic Resonance Imaging;

Countries

China

Contacts

Public ContactXingrong Song

Guangzhou Medical University Affiliated Women and Children's Medical Center

sxjess@126.com+86 139 2241 6303

Outcome results

None listed

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