Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-12
SponsorNanjing Children's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Esketamine
  • Normal Saline

Treatment groups

342 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Nanjing Children's Hospital

Lead sponsor

Zhongda Hospital

Collaborator

Nanjing First Hospital, Nanjing Medical University

Collaborator

Wuxi Women's & Children's Hospital

Collaborator