Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children (PEDI-NPOBCs)

Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavior Problem
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Esketamine; Drug: Normal Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 342
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Zhang, Doctoral degree; Phone Number: +86 138 1540 6629; Email: drzhangli@njmu.edu.cn
• Study Contact Backup: Name: Fei Sun, Master's degree; Phone Number: +86 181 0061 9994; Email: drsunfei89@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Children's Hospital of Nanjing Medical University
      • Contact: Medical Ethics Committee of Children's Hospital of Nanjing Med; Phone Number: +86 189 5176 2937; Email: drsunfei@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 2 to 12 years.
2. Scheduled to undergo elective day surgery under general anesthesia.
3. ASA (American Society of Anesthesiologists) physical status I to III.

Exclusion Criteria:

1. Congenital diseases or severe liver or kidney dysfunction.
2. History of allergic reactions to study drugs.
3. Neuromuscular diseases, cerebral palsy, epilepsy.
4. Other psychiatric or neurological disorders.
5. Body mass index (BMI) ≥ 30 kg/m².
6. Severe upper respiratory tract infections prior to surgery.
7. Use of sedatives or analgesics within 48 hours before surgery.
8. Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).
9. Refusal to participate or failure to obtain consent from the child's legal guardian.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal Dexmedetomidine; Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.	Drug: Dexmedetomidine; Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.; Other Names: Dexmedetomidine Hydrochloride
Experimental: Intranasal Esketamine; Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.	Drug: Esketamine; Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.; Other Names: Esketamine Hydrochloride
Placebo Comparator: Normal Saline Control; Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.	Drug: Normal Saline; Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.; Other Names: 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Postoperative Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Postoperative Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	In the post-anesthesia care unit on the day of surgery
Postoperative Time to Discharge	Time from the end of surgery to hospital discharge.	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.	On the day of surgery before discharge

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital
• Collaborators: Nanjing First Hospital, Nanjing Medical University; Zhongda Hospital; Wuxi Women's & Children's Hospital
• Investigators: Principal Investigator: fei sun, Master's, Children's Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Children; Randomized Controlled Trial; Dexmedetomidine; Esketamine; General Anesthesia; Emergence Delirium; Intranasal Premedication; Pediatric Day Surgery; Negative Postoperative Behavioral Changes; Perioperative Electroencephalography
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Mental Disorders; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Imidazoles; Inorganic Chemicals; Chlorine Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Sodium Compounds; Chlorides; Hydrochloric Acid; Esketamine; Dexmedetomidine; Saline Solution; Sodium Chloride
• Other Study ID Numbers: 202512066-2; SWYY2025002065 (Other Grant/Funding Number: ISEFC, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No