Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children

NCT07570160 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 202512066-2SWYY2025002065
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavior Problem

Keywords

Dexmedetomidine; Esketamine; Intranasal Premedication; Pediatric Day Surgery; Negative Postoperative Behavioral Changes; Emergence Delirium; Perioperative Electroencephalography; General Anesthesia; Children; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3

  Postoperative Day 3

• Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28

  Postoperative Day 28

Other Outcomes (8)

• Sedation Score 30 Minutes After Study Drug Administration

  30 minutes after study drug administration

• Postoperative Pain Score

  At the time of emergence in the post-anesthesia care unit

• Emergence Delirium Score

  After emergence in the post-anesthesia care unit

Study Arms (3)

Intranasal Dexmedetomidine

EXPERIMENTAL

Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.

Drug: Dexmedetomidine

Intranasal Esketamine

EXPERIMENTAL

Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.

Drug: Esketamine

Normal Saline Control

PLACEBO COMPARATOR

Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.

Also known as: Dexmedetomidine Hydrochloride

Intranasal Dexmedetomidine

Esketamine DRUG

Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.

Also known as: Esketamine Hydrochloride

Intranasal Esketamine

Normal Saline DRUG

Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.

Also known as: 0.9% Sodium Chloride

Normal Saline Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing Children's Hospital: lead
• Zhongda Hospital: collaborator
• Wuxi Women's & Children's Hospital: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Mental Disorders; Emergence Delirium

Interventions

Dexmedetomidine; Esketamine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• fei sun, Master's

  Children's Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Sun, Master's degree

CONTACT

+86 181 0061 9994; drsunfei89@163.com

Li Zhang, Doctoral degree

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)