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A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Low-Concentration Sevoflurane in Patients with Autism Spectrum Disorder

A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Low-Concentration Sevoflurane in Patients with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096191
Enrollment
Unknown
Registered
2025-01-20
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

The Affiliated Women and Children’s Medical Center of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for Autism Spectrum Disorder (ASD) as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 2. Age between 3 and 18 years, regardless of gender; 3. Participants must be able to complete all assessments; 4. Parents or legal guardians of participants must have good reading and comprehension skills and be able to cooperate with filling out relevant assessment scales and follow-ups; 5. Parents or legal guardians must provide written informed consent to voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1. Other mental disorders excluding Autism Spectrum Disorder (such as epilepsy, schizophrenia, cerebral ischemia and hypoxia, encephalitis, history of traumatic brain injury, poisoning, etc.); 2. Presence of severe somatic diseases or other systemic diseases (related history of renal, hepatic, metabolic disorders, tumors, infections, organic diseases of the nervous system, endocrine or immune diseases, etc.); 3. Serum K+ or Mg2+ levels exceeding the normal range; 4. History of malignant neuroleptic syndrome or tardive dyskinesia; 5. Use of monoamine oxidase inhibitors antidepressants in the 2 weeks prior to the study; 6. Use of antipsychotic medications such as risperidone in the 3 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-2;

Secondary

MeasureTime frame
Autistic Behavior Checklist;Autism Treatment Evaluation Checklist Score;Clinical Global Impression-Severity;Clinical Global Impression-Improvement;

Countries

China

Contacts

Public ContactXingrong Song

The Affiliated Women and Children’s Medical Center of Guangzhou Medical University

sxjess@126.com+86 139 2241 6303

Outcome results

None listed

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