Autism Spectrum DisorderNPOBCsNCT07324057
The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
A study testing Intranasal dexmedetomidine and Intranasal Esketamine in people with Autism Spectrum Disorder, run by Sun Fei at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Intranasal dexmedetomidine and Intranasal Esketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Medical Ethics Committee of Children's Hospital of Nanjing Med, +86 189 5176 2937, drsunfei89@163.com
About this study
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:
Read more
- 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
Read the detailed description
This study is a multicenter, prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of preoperative intranasal sedation on negative postoperative behavioral changes (NPOBCs) in children with autism spectrum disorder (ASD) undergoing elective surgery under general anesthesia Children with ASD often experience heightened perioperative anxiety, sensory sensitivity, and difficulty adapting to unfamiliar medical environments. These factors place them at increased risk for NPOBCs, which may include emotional distress, irritability, sleep disturbances, fear-related behaviors, and reduced cooperation with medical care after surgery. Effective and well-tolerated preoperative sedation may help reduce perioperative stress responses and improve postoperative behavioral outcomes. However, high-quality evidence in children with ASD remains limited.
This study will enroll a total of 234 participants across multiple pediatric hospitals. Participants will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: intranasal dexmedetomidine, intranasal esketamine, or intranasal saline as a control. Randomization will be centrally managed using a stratified block design to balance study center, age group, and surgical category. Blinding will be maintained for participants, caregivers, anesthesiologists, outcome assessors, and data analysts to minimize bias.
Study medication will be administered intranasally approximately thirty minutes before anesthesia induction using identical, unlabeled nasal spray devices. All participants will then receive routine general anesthesia and perioperative management according to standard clinical practice at each participating center. The surgical procedure and anesthetic technique will not be altered by study participation.
The primary objective of the study is to compare the incidence of NPOBCs seven days after surgery among the three groups. Behavioral outcomes will be assessed using validated caregiver-reported questionnaires appropriate for children with ASD. Secondary objectives include evaluating behavioral changes at three and twenty-eight days after surgery, emergence agitation during recovery, postoperative pain, quality of preoperative sedation, and overall safety.
In addition to clinical and behavioral assessments, electroencephalographic (EEG) data will be collected during the emergence period from anesthesia. These data will be analyzed to explore potential associations between neurophysiological patterns and subsequent behavioral outcomes. This exploratory component aims to support the development of predictive models for postoperative behavioral risk in children with ASD.
Participant safety is a key priority. All adverse events will be systematically recorded and reviewed in accordance with Good Clinical Practice guidelines. Serious adverse events will be reported promptly and reviewed by an independent data and safety monitoring process. Ongoing safety oversight will include regular review of adverse event rates across study centers.
The study is expected to provide clinically relevant evidence on whether intranasal dexmedetomidine or intranasal esketamine administered before anesthesia can reduce postoperative behavioral disturbances in children with ASD. Findings from this trial may help inform future perioperative management strategies and support more individualized, evidence-based care for this vulnerable population.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Intranasal dexmedetomidine, Intranasal Esketamine, saline control
- Keywords
- Children;Anesthetic agents;Autism Spectrum Disorder;Electroencephalography;Negative postoperative behavioural changes
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Also called · Dexmedetomidine nasal spray · Intranasal dexmedetomidine · Dexmedetomidine intranasal spray · Dexmedetomidine intranasal group (D group)
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.
Intranasal EsketamineDrug
Also called · Esketamine nasal spray · Intranasal esketamine · Esketamine intranasal spray · Esketamine intranasal group (K group)
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.
saline controlDrug
Also called Normal saline Physiological saline Intranasal saline Normal saline nasal spray (1 mL) Saline control group (C group)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intranasal Esketamine |
| Saline Control Group (C Group) | Placebo comparator | Participants receive normal saline 1 milliliter administered intranasally approximately 30 minutes before anesthesia induction. Receives: Drug: saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 3 and postoperative day 28, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS) during postoperative follow-up. NPOBCs are defined as new or worsened maladaptive behaviors after anesthesia/surgery, which may include changes such as sleep disturbance, altered eating patterns, emotional dysregulation (e.g., irritability/anxiety), medical-related fears, and reduced treatment cooperation. Follow-up assessments are performed by an independent researcher blinded to group allocation.
Measured: Postoperative day 3 and postoperative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Fei
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital
- Responsible party
- Sponsor-investigator, Sun Fei, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324057
- Sponsor's protocol ID
- 202504034-2
- Other IDs
- 202511028
- Acronym
- NPOBCs
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there are no plans to share individual participant data (IPD) from this study. The decision may be revisited in the future based on data confidentiality, privacy concerns, and any relevant regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07324057
- Acronym / sponsor ID
- NPOBCs / 202504034-2
- Conditions
- Autism Spectrum Disorder
- Keywords
- Children;Anesthetic agents;Autism Spectrum Disorder;Electroencephalography;Negative postoperative behavioural changes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Sun FeiUniversity, hospital or other
- Collaborators
- Zhongda Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a multicenter, prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of preoperative intranasal sedation on negative postoperative behavioral changes (NPOBCs) in children with autism spectrum disorder (ASD) undergoing elective surgery under general anesthesia Children with ASD often experience heightened perioperative anxiety, sensory sensitivity, and difficulty adapting to unfamiliar medical environments. These factors place them at increased risk for NPOBCs, which may include emotional distress, irritability, sleep disturbances, fear-related behaviors, and reduced cooperation with medical care after surgery. Effective and well-tolerated preoperative sedation may help reduce perioperative stress responses and improve postoperative behavioral outcomes. However, high-quality evidence in children with ASD remains limited.
This study will enroll a total of 234 participants across multiple pediatric hospitals. Participants will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: intranasal dexmedetomidine, intranasal esketamine, or intranasal saline as a control. Randomization will be centrally managed using a stratified block design to balance study center, age group, and surgical category. Blinding will be maintained for participants, caregivers, anesthesiologists, outcome assessors, and data analysts to minimize bias.
Study medication will be administered intranasally approximately thirty minutes before anesthesia induction using identical, unlabeled nasal spray devices. All participants will then receive routine general anesthesia and perioperative management according to standard clinical practice at each participating center. The surgical procedure and anesthetic technique will not be altered by study participation.
The primary objective of the study is to compare the incidence of NPOBCs seven days after surgery among the three groups. Behavioral outcomes will be assessed using validated caregiver-reported questionnaires appropriate for children with ASD. Secondary objectives include evaluating behavioral changes at three and twenty-eight days after surgery, emergence agitation during recovery, postoperative pain, quality of preoperative sedation, and overall safety.
In addition to clinical and behavioral assessments, electroencephalographic (EEG) data will be collected during the emergence period from anesthesia. These data will be analyzed to explore potential associations between neurophysiological patterns and subsequent behavioral outcomes. This exploratory component aims to support the development of predictive models for postoperative behavioral risk in children with ASD.
Participant safety is a key priority. All adverse events will be systematically recorded and reviewed in accordance with Good Clinical Practice guidelines. Serious adverse events will be reported promptly and reviewed by an independent data and safety monitoring process. Ongoing safety oversight will include regular review of adverse event rates across study centers.
The study is expected to provide clinically relevant evidence on whether intranasal dexmedetomidine or intranasal esketamine administered before anesthesia can reduce postoperative behavioral disturbances in children with ASD. Findings from this trial may help inform future perioperative management strategies and support more individualized, evidence-based care for this vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Intranasal Spray (D Group) | Experimental | Drug: Intranasal dexmedetomidineParticipants 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. |
| Esketamine Intranasal Spray (L Group) | Experimental | Drug: Intranasal EsketamineParticipants receive esketamine 1 milligram per kilogram (maximum 50 milligrams), diluted to 1 milliliter and administered intranasally approximately 30 minutes before anesthesia induction. |
| Saline Control Group (C Group) | Placebo comparator | Drug: saline controlParticipants receive normal saline 1 milliliter administered intranasally approximately 30 minutes before anesthesia induction. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal dexmedetomidineAlso: · Dexmedetomidine nasal spray · Intranasal dexmedetomidine · Dexmedetomidine intranasal spray · Dexmedetomidine intranasal group (D group)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. | Drug | Dexmedetomidine Intranasal Spray (D Group) |
| Intranasal EsketamineAlso: · Esketamine nasal spray · Intranasal esketamine · Esketamine intranasal spray · Esketamine intranasal group (K group)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. | Drug | Esketamine Intranasal Spray (L Group) |
| saline controlAlso: Normal saline Physiological saline Intranasal saline Normal saline nasal spray (1 mL) Saline control group (C group)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. | Drug | Saline Control Group (C Group) |
Primary outcome
Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 7, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS).
Time frame: Postoperative day 7
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.
1 secondary outcome
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).
Time frame: Postoperative day 3 and postoperative day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. At this time, there are no plans to share individual participant data (IPD) from this study. The decision may be revisited in the future based on data confidentiality, privacy concerns, and any relevant regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal dexmedetomidine and Intranasal Esketamine in people with Autism Spectrum Disorder, run by Sun Fei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctoral degree (+86 138 1540 6629, drzhangli@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 7, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS). (time frame: Postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.