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Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children

NCT07570160 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

Intranasal dexmedetomidine 2.0 micrograms/kg administered once 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.

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Zhongda Hospital

    collaborator OTHER

  • Nanjing First Hospital, Nanjing Medical University

    collaborator OTHER

  • Wuxi Women's & Children's Hospital

    collaborator OTHER

  • Nanjing Children's Hospital

    lead OTHER

Principal Investigators

  • fei sun, Master's · Children's Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570160 on ClinicalTrials.gov