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

NCT07324057 | Recruiting DMC

• 2 other identifiers: 202504034-2202511028
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autism Spectrum Disorder

Keywords

Children;Anesthetic agents;Autism Spectrum Disorder;Electroencephalography;Negative postoperative behavioural changes

Outcome Measures

Primary Outcomes (1)

• Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 7, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS).

  Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 7, assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). NPOBCs refer to new or worsened maladaptive behaviors after anesthesia/surgery (e.g., sleep disturbance, changes in eating behavior, emotional dysregulation such as irritability/anxiety, and medical-related fears). The day-7 PHBQ-AS assessment will be collected during postoperative follow-up performed by an independent researcher who is blinded to group allocation.

  Postoperative day 7

Secondary Outcomes (1)

• Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 1 and postoperative day 30, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS).

  Postoperative day 3 and postoperative day 28

Other Outcomes (1)

• Additional protocol-defined outcome measures collected and analyzed as planned, but not labeled primary or secondary (e.g., exploratory/tertiary); exclude post-hoc measures.

  From 30 minutes after study drug administration through surgery, emergence/awakening, and the postoperative hospital stay (until discharge).

Study Arms (3)

Dexmedetomidine Intranasal Spray (D Group)

EXPERIMENTAL

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.

Drug: Intranasal dexmedetomidine

Esketamine Intranasal Spray (L Group)

EXPERIMENTAL

Participants receive esketamine 1 milligram per kilogram (maximum 50 milligrams), diluted to 1 milliliter and administered intranasally approximately 30 minutes before anesthesia induction.

Drug: Intranasal Esketamine

Saline Control Group (C Group)

PLACEBO COMPARATOR

Participants receive normal saline 1 milliliter administered intranasally approximately 30 minutes before anesthesia induction.

Drug: saline control

Interventions

Intranasal dexmedetomidine DRUG

Dosage: 2.0 µg/kg (maximum 100 µg) Administration: Intranasal spray, 30 minutes before anesthesia induction Purpose: To provide sedation, reduce preoperative anxiety, and potentially prevent postoperative behavioral issues like agitation and delirium.

Also known as: · Dexmedetomidine nasal spray · Intranasal dexmedetomidine · Dexmedetomidine intranasal spray · Dexmedetomidine intranasal group (D group)

Dexmedetomidine Intranasal Spray (D Group)

Intranasal Esketamine DRUG

Dosage: 1.0 mg/kg (maximum 50 mg) Administration: Intranasal spray, 30 minutes before anesthesia induction Purpose: To provide sedation, reduce anxiety, and minimize postoperative behavioral changes like aggression and agitation.

Also known as: · Esketamine nasal spray · Intranasal esketamine · Esketamine intranasal spray · Esketamine intranasal group (K group)

Esketamine Intranasal Spray (L Group)

saline control DRUG

Dosage: Equal volume of saline (1 ml) Administration: Intranasal spray, 30 minutes before anesthesia induction Purpose: To serve as a placebo control, allowing comparison to the active intervention groups.

Also known as: Normal saline Physiological saline Intranasal saline Normal saline nasal spray (1 mL) Saline control group (C group)

Saline Control Group (C Group)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Fei: lead
• Zhongda Hospital: collaborator

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Li Zhang, Doctoral degree

CONTACT

+86 138 1540 6629; drzhangli@njmu.edu.cn

Fei Sun, Master's Degree

CONTACT

+86 181 0061 9994; drsunfei@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employed a double-blind design for both investigators and patients. Approximately 30 minutes prior to surgery, the paediatric patient was admitted to the anaesthesia preparation room. An anaesthesia nurse not involved in the study received the randomisation allocation results from the centralised system and prepared the corresponding formulations. The study medication was administered via identical, unlabelled nasal spray pumps, All formulations were diluted to 1 ml and then loaded into sterile, unlabelled nasal spray pumps. These were handed to the study intervention implementer, who remained unaware of the administered drug and withdrew from the study upon completion of the intervention. Subsequently, all investigators remained unaware of the group allocation. Postoperative follow-up was conducted by another independent investigator, and data analysis was performed by a statistical expert not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)