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The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Children's Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Li Zhang, Doctoral degree
drzhangli@njmu.edu.cn
+86 138 1540 6629
Backup
Fei Sun, Master's Degree
drsunfei@njmu.edu.cn
+86 181 0061 9994
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 234
Treatments
Experimental: Dexmedetomidine Intranasal Spray (D Group)
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.
Experimental: Esketamine Intranasal Spray (L Group)
Participants receive esketamine 1 milligram per kilogram (maximum 50 milligrams), diluted to 1 milliliter and administered intranasally approximately 30 minutes before anesthesia induction.
Placebo_comparator: Saline Control Group (C Group)
Participants receive normal saline 1 milliliter administered intranasally approximately 30 minutes before anesthesia induction.
Related Therapeutic Areas
Sponsors
Leads: Sun Fei
Collaborators: Zhongda Hospital

This content was sourced from clinicaltrials.gov