Actively Recruiting

Phase Not Applicable
Age: 2Years - 12Years
All Genders
NCT07324057

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

Led by Sun Fei · Updated on 2026-04-15

234

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

S

Sun Fei

Lead Sponsor

Z

Zhongda Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 12 years
  • Diagnosed with Autism Spectrum Disorder by a psychiatrist
  • Scheduled for elective surgery under general anesthesia
  • ASA physical status I to III
Not Eligible

You will not qualify if you...

  • Undergoing cardiac, thoracic/pulmonary, or neurosurgery
  • Having congenital disease or severe liver or kidney dysfunction
  • Allergic to study drugs
  • Diagnosed with neuromuscular disease, cerebral palsy, epilepsy, or other psychiatric/neurologic disorders
  • Body mass index 30 kg/m² or higher
  • Severe upper respiratory tract infection before surgery
  • Used sedatives or pain medicines within 48 hours before surgery
  • Experienced major life stressors within 1 month before surgery (e.g., family or school change, parental divorce or death)
  • Parent or guardian refuses participation

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

L

Li Zhang, Doctoral degree

CONTACT

F

Fei Sun, Master's Degree

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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