A Phase 4 interventional study of Dexmedetomidine and Esketamine in Behavior Problem, sponsored by Nanjing Children's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Nanjing Children's Hospital · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.
The main questions this study aims to answer are:
Does intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.
Participants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.
This multicenter, prospective, randomized, double-blind, controlled clinical trial will evaluate whether preoperative intranasal dexmedetomidine or esketamine can reduce negative postoperative behavioral changes in children undergoing day surgery under general anesthesia. The study will also explore whether perioperative electroencephalographic (EEG) features are associated with these behavioral changes and may help explain the effects of the study drugs.
A total of 342 children undergoing elective day surgery will be enrolled across four centers. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive intranasal dexmedetomidine 2.0 micrograms/kg, intranasal esketamine 1.0 mg/kg, or an equal volume of normal saline approximately 30 minutes before induction of anesthesia. Study medications will be prepared in identical, unlabeled nasal spray devices to maintain blinding. Participants, investigators, and outcome assessors will remain unaware of treatment assignment throughout the study.
After study drug administration, participants will undergo routine perioperative monitoring. Sedation will be assessed before surgery. During anesthesia and recovery, EEG and other perioperative clinical data will be collected. Postoperative assessments will include pain and emergence delirium. Negative postoperative behavioral changes will be evaluated on postoperative days 3, 7, and 28. The primary outcome is the incidence of negative postoperative behavioral changes on postoperative day 7. Secondary analyses will assess behavioral outcomes at postoperative days 3 and 28 and examine the relationship between perioperative EEG patterns and postoperative behavioral changes.
This study is designed to provide evidence on the comparative effects of intranasal dexmedetomidine and esketamine on postoperative behavioral recovery in children undergoing day surgery and to identify perioperative EEG markers that may be associated with adverse behavioral outcomes.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 342 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
Drug: Dexmedetomidine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
Drug: Esketamine
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
Drug: Normal Saline
Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Also known as: Dexmedetomidine Hydrochloride
Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Also known as: Esketamine Hydrochloride
Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Also known as: 0.9% Sodium Chloride
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Time frame: Postoperative Day 7
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Time frame: Postoperative Day 3
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Time frame: Postoperative Day 28
Sedation Score 30 Minutes After Study Drug Administration
Sedation level assessed 30 minutes after study drug administration using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Scores range from 0 to 5, with 0 indicating no response to painful stimulus and 5 indicating fully alert. Higher scores indicate better alertness and less sedation.
Time frame: 30 minutes after study drug administration
Postoperative Pain Score
Pain intensity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Scores range from 0 to 10, with higher scores indicating worse pain.
Time frame: At the time of emergence in the post-anesthesia care unit
Emergence Delirium Score
Emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Scores range from 0 to 20, with higher scores indicating worse emergence delirium.
Time frame: After emergence in the post-anesthesia care unit
Intraoperative Electroencephalographic Parameters Before Emergence Description
Electroencephalographic parameters derived from raw intraoperative electroencephalography recordings obtained from after induction of anesthesia until before emergence. Reported values will be summarized from the recorded electroencephalographic data.
Time frame: From induction of anesthesia until before emergence
Incidence of Perioperative Adverse Events
Incidence of perioperative adverse events, including nausea, vomiting, allergic reactions, emergence delirium, and other adverse behavioral or physiological events occurring in children during the immediate postoperative period. All adverse events are continuously monitored and recorded by trained clinical staff using standardized observation procedures and behavioral scales (e.g., PAED scale for emergence delirium). The observation period includes the entire post-anesthesia care unit stay until the child meets discharge criteria.
Time frame: From administration of study drug until discharge from the post-anesthesia care unit, assessed up to the maximum expected PACU stay (varies by individual, typically 1-4 hours)
Emergence Time
Time from discontinuation of anesthesia to emergence.
Time frame: In the post-anesthesia care unit on the day of surgery
Postoperative Time to Discharge
Time from the end of surgery to hospital discharge.
Time frame: From end of surgery to discharge on the day of surgery
Parental Satisfaction Score Assessed by the Pediatric Anesthesia Parent Satisfaction (PAPS) Questionnaire
Parental satisfaction with perioperative management assessed on the day of surgery before discharge using the Pediatric Anesthesia Parent Satisfaction (PAPS) questionnaire. The questionnaire includes 15 items, and total scores range from 15 to 75, calculated as the sum of all item scores. Higher scores indicate greater parental satisfaction.
Time frame: On the day of surgery before discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Start is estimated for Jun 2026; primary completion for Nov 2027, 17 months later.
Of 17 phase 4 interventional studies under Mental Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 84. This study's planned 17 months is below that.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Esketamine
Nanjing Children's Hospital