Pre-surgery intranasal dexmedetomidine or esketamine to reduce negative behaviors after anesthesia in children with autism
The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
NA · Nanjing Children's Hospital · NCT07324057
We will test whether a single intranasal dose of dexmedetomidine or esketamine given before anesthesia can lower negative behavioral changes seven days after surgery in children aged 2–12 with autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Nanjing Children's Hospital (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07324057 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled multicenter trial will assign 234 children with autism spectrum disorder undergoing elective general anesthesia to intranasal dexmedetomidine, intranasal esketamine, or intranasal saline in a 1:1:1 ratio. Study medication is administered about 30 minutes before anesthesia and blinding is maintained for caregivers, clinicians, and outcome assessors. The primary outcome is negative postoperative behavioral changes measured seven days after surgery, with secondary outcomes including postoperative agitation, pain, sedation quality, safety events, and peri-recovery EEG patterns. Randomization is centrally managed with stratified block design by center, age group, and surgical category to balance groups.
Who should consider this trial
Good fit: Children aged 2–12 years with a psychiatrist-diagnosed autism spectrum disorder, ASA physical status I–III, scheduled for elective surgery under general anesthesia and meeting inclusion criteria are ideal candidates.
Not a fit: Children having cardiac, thoracic, or neurosurgery, or those with epilepsy, severe hepatic/renal dysfunction, recent sedative use, major comorbid psychiatric/neurologic disorders, severe upper respiratory infection, or other listed exclusions are unlikely to receive benefit from these interventions.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative emotional distress and behavioral problems in autistic children recovering from surgery.
How similar studies have performed: Intranasal dexmedetomidine has shown benefit for reducing emergence agitation in pediatric populations, but direct comparisons with intranasal esketamine and focused evidence in children with autism are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 2-12 years ASA physical status I-III Diagnosed with Autism Spectrum Disorder (ASD) by a psychiatrist Scheduled for elective surgery under general anesthesia Exclusion Criteria: * Cardiac, thoracic/pulmonary, or neurosurgery Congenital disease or severe hepatic/renal dysfunction Allergy to study drugs Neuromuscular disease, cerebral palsy, or epilepsy Other psychiatric or neurologic disorders BMI ≥30 kg/m² Severe upper respiratory tract infection preoperatively Sedatives or analgesics used within 48 hours preoperatively Major life stressor within 1 month pre-op (e.g., family/school change, parental divorce or death) Parent/guardian refuses participation
Where this trial is running
Nanjing, Jiangsu
- Children's Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Li Zhang, Doctoral degree
- Email: drzhangli@njmu.edu.cn
- Phone: +86 138 1540 6629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Children, Anesthetic agents, Electroencephalography, Negative postoperative behavioural changes