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Effects of dexmedetomidine on cognitive and behavioral changes in children with autism after caries treatment under general anesthesia

Effects of dexmedetomidine on cognitive and behavioral changes in children with autism after caries treatment under general anesthesia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103480
Enrollment
Unknown
Registered
2025-05-29
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile autism

Interventions

Autism + Saline (Group A):Group A was given equal dose of normal saline
Autism + dexmedetomidine (Group A+D):Patients in group A+D were given intravenous dexmedetomidine at 0.20-0.40 µg/(kg·h) after anesthesia

Sponsors

Stomatology Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Children with autism: 1) The biological age is 2-12 years old; 2) Meet the diagnostic criteria for autism spectrum disorder in the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3) Children diagnosed with ASD by the ADORS2 gold Standard for autism assessment; 4) General anesthesia caries were treated in our hospital and no contraindications were detected by anesthesiologists in our department; 5) Subject's guardian signs the informed consent. Normal children: 1) No child mental illness or other heart, lung, kidney and other physical diseases 2) General anesthesia caries were treated in our hospital and no contraindications were detected by anesthesiologists in our department 3) Subject's guardian signs the informed consent

Exclusion criteria

Exclusion criteria: Children with autism: 1) accompanied by other serious heart, lung, kidney and other physical diseases; 2) Received general anesthesia within three months; 3) Allergic to Dex; 4) Other sedatives have been used within 48 hours; 5) bradycardia; 6) Respiratory infection; 7) Any person who has difficulty in understanding the test plan and cannot follow the test plan Normal children: 1) accompanied by other serious heart, lung, kidney and other physical diseases; 2) Received general anesthesia within three months; 3) Allergic to Dex; 4) Other sedatives have been used within 48 hours; 5) bradycardia; 6) Respiratory infection; 7) Any person who has difficulty in understanding the test plan and cannot follow the test plan

Design outcomes

Primary

MeasureTime frame
Autism Treatment Assessment Scale (ATEC);Behavioral Checklist for Autistic Children (ABC);

Secondary

MeasureTime frame
Recovery from general anesthesia in children (PAED score);Pain scores for children during recovery;Expiration time;Awakening time;Pre-anesthetic vital signs;Tracheal catheter was inserted into immediate vital signs;Tracheal catheter removal is vital sign;Wake up with vital signs;Regular medication;Postoperative respiratory depression;nausea and vomiting;Bed fall event;

Countries

China

Contacts

Public ContactXiaoping Zhang

Stomatology Hospital Affiliated to Wenzhou Medical University

pingguo106@126.com+86 137 3203 1279

Outcome results

None listed

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