Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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.

Eligibility

Primary outcome measure(s)

• Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7 — Postoperative Day 7
  Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

Trial sites (1)

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