Trial · NCT07324057
The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
NCT07324057, Not applicable, Recruiting, Sun Fei
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder. Trials, record NCT07324057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07324057
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavioral Changes in Children With Autism Spectrum Disorder
- NCT number
- NCT07324057
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 234 participants, estimated
- Lead sponsor
- Sun Fei
- Conditions
- Autism Spectrum Disorder
- Interventions
- Intranasal dexmedetomidine, Intranasal Esketamine, saline control
- First posted
- 2026-01-07
- Last updated
- 2026-04-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of negative postoperative behavioral changes (NPOBCs) at postoperative day 7, assessed using the Post Hospitalization Behavior Questionnaire for Autism Spectrum Disorder (PHBQ-AS). | 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. |
| Secondary | 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 | 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. |
| Other | 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). | This trial's other pre-specified outcomes include: sedation 30 minutes after study drug administration measured with MOAA/S; pain after awakening measured with FLACC; emergence delirium/agitation after awakening measured with PAED; intraoperative and emergence EEG features; perioperative adverse events (e.g., nausea/vomiting, allergy); awakening time and postoperative length of stay; and parent satisfaction. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07324057
GET https://conductscience.org/api/trials/v1/NCT07324057/registered