Nasal sedatives before surgery and behavior changes in autistic children
Tests nasal dexmedetomidine and esketamine before surgery in children with autism spectrum disorder.
Key facts
- Who runs it
- Sun Fei
- Where
- Nanjing, ChinaSee the site
- Trial code
- Registry title
- The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
- Status
- Recruiting
- People taking part
- 234 people, planned
- Started
- 1 Apr 2026
- Expected to end
- 30 Nov 2027
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Intranasal dexmedetomidine
- Intranasal Esketamine
- saline control
- Record updated
- 15 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with autism spectrum disorder who are scheduled for planned surgery under general anesthesia.
- Age
- 2 to 12 years
- Sex
- All sexes
- Disease stage
- Autism spectrum disorder diagnosed by a psychiatrist; ASA physical status I-III; planned (elective) surgery under general anesthesia
- Earlier treatment
- No sedatives or painkillers within 48 hours before surgery
Main reasons for not taking part
- Heart, chest/lung or brain surgery
- Congenital disease or severe liver or kidney problems
- Allergy to the study drugs
- Neuromuscular disease, cerebral palsy or epilepsy
- Other psychiatric or neurologic disorders
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 12 years old?
Where in China
- Children's Hospital of Nanjing Medical UniversityNanjing, ChinaContact: Medical Ethics Committee of Children's Hospital of Nanjing MedTaking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn whether intranasal sedation given before anesthesia can lower negative postoperative behavioral changes in children with autism spectrum disorder who undergo elective surgery. The study will compare two commonly used sedative medicines with a saline control. It will also examine the safety of these medicines and explore how brain electrical activity during recovery may relate to later behavior changes.
Read full original descriptionShow less
The main questions this study aims to answer are:
* Does intranasal dexmedetomidine given before anesthesia lower negative postoperative behavioral changes seven days after surgery in children with autism spectrum disorder?
* Does intranasal esketamine given before anesthesia lower negative postoperative behavioral changes seven days after surgery in children with autism spectrum disorder?
* Are there differences in postoperative agitation, pain, and sedation quality among the three groups? Researchers will compare dexmedetomidine, esketamine, and saline to see whether either medicine works better than saline in reducing postoperative behavior changes.
Participants will:
* Be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal saline about thirty minutes before anesthesia
* Undergo their planned surgery with standard general anesthesia care ③ Be assessed for behavior changes at three, seven, and twenty-eight days after surgery ④ Have routine monitoring of recovery, pain, agitation, and safety outcomes during and after surgery
The 3 groups in the trial
- Dexmedetomidine Intranasal Spray (D Group)Treatment being tested
Participants assigned to the Dexmedetomidine Intranasal Spray receive dexmedetomidine at a dose of 2 micrograms per kilogram (maximum 100 micrograms), diluted to 1 milliliter and administered intranasally approximately 30 minutes before anesthesia induction.
Treatment: Intranasal dexmedetomidine
- Esketamine Intranasal Spray (L Group)Treatment being tested
Participants receive esketamine 1 milligram per kilogram (maximum 50 milligrams), diluted to 1 milliliter and administered intranasally approximately 30 minutes before anesthesia induction.
Treatment: Intranasal Esketamine
- Saline Control Group (C Group)Placebo, for comparison
Participants receive normal saline 1 milliliter administered intranasally approximately 30 minutes before anesthesia induction.
Treatment: saline control
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
- Plain-language title
- Nasal sedatives before surgery and behavior changes in autistic childrenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07324057, who can take part
- Record updated
- 15 April 2026