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.
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.
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.
Parallel
Dexmedetomidine
DrugIntranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Esketamine
DrugIntranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Normal Saline
DrugIntranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
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).
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).
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).
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.
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.
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.
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.
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Nanjing Children's Hospital
Lead sponsor
Zhongda Hospital
Collaborator
Nanjing First Hospital, Nanjing Medical University
Collaborator
Wuxi Women's & Children's Hospital
Collaborator
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