Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children (PEDI-NPOBCs)
Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This multicenter, prospective, randomized, double-blind, controlled clinical trial will evaluate whether preoperative intranasal dexmedetomidine or esketamine can reduce negative postoperative behavioral changes in children undergoing day surgery under general anesthesia. The study will also explore whether perioperative electroencephalographic (EEG) features are associated with these behavioral changes and may help explain the effects of the study drugs.
A total of 342 children undergoing elective day surgery will be enrolled across four centers. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive intranasal dexmedetomidine 2.0 micrograms/kg, intranasal esketamine 1.0 mg/kg, or an equal volume of normal saline approximately 30 minutes before induction of anesthesia. Study medications will be prepared in identical, unlabeled nasal spray devices to maintain blinding. Participants, investigators, and outcome assessors will remain unaware of treatment assignment throughout the study.
After study drug administration, participants will undergo routine perioperative monitoring. Sedation will be assessed before surgery. During anesthesia and recovery, EEG and other perioperative clinical data will be collected. Postoperative assessments will include pain and emergence delirium. Negative postoperative behavioral changes will be evaluated on postoperative days 3, 7, and 28. The primary outcome is the incidence of negative postoperative behavioral changes on postoperative day 7. Secondary analyses will assess behavioral outcomes at postoperative days 3 and 28 and examine the relationship between perioperative EEG patterns and postoperative behavioral changes.
This study is designed to provide evidence on the comparative effects of intranasal dexmedetomidine and esketamine on postoperative behavioral recovery in children undergoing day surgery and to identify perioperative EEG markers that may be associated with adverse behavioral outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Li Zhang, Doctoral degree
- Número de teléfono: +86 138 1540 6629
- Correo electrónico: drzhangli@njmu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Fei Sun, Master's degree
- Número de teléfono: +86 181 0061 9994
- Correo electrónico: drsunfei89@163.com
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210008
- Children's Hospital of Nanjing Medical University
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Contacto:
- Medical Ethics Committee of Children's Hospital of Nanjing Med
- Número de teléfono: +86 189 5176 2937
- Correo electrónico: drsunfei@njmu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
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Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Otros nombres:
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Experimental: Intranasal Esketamine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
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Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Otros nombres:
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Comparador de placebos: Normal Saline Control
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
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Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Periodo de tiempo: Postoperative Day 7
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 7
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Periodo de tiempo: Postoperative Day 3
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 3
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Periodo de tiempo: Postoperative Day 28
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 28
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sedation Score 30 Minutes After Study Drug Administration
Periodo de tiempo: 30 minutes after study drug administration
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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.
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30 minutes after study drug administration
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Postoperative Pain Score
Periodo de tiempo: At the time of emergence in the post-anesthesia care unit
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Pain intensity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
Scores range from 0 to 10, with higher scores indicating worse pain.
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At the time of emergence in the post-anesthesia care unit
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Emergence Delirium Score
Periodo de tiempo: After emergence in the post-anesthesia care unit
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Emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.
Scores range from 0 to 20, with higher scores indicating worse emergence delirium.
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After emergence in the post-anesthesia care unit
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Intraoperative Electroencephalographic Parameters Before Emergence Description
Periodo de tiempo: From induction of anesthesia until before emergence
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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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From induction of anesthesia until before emergence
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Incidence of Perioperative Adverse Events
Periodo de tiempo: From administration of study drug until discharge from the post-anesthesia care unit, assessed up to the maximum expected PACU stay (varies by individual, typically 1-4 hours)
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Incidence of perioperative adverse events, including nausea, vomiting, allergic reactions, emergence delirium, and other adverse behavioral or physiological events occurring in children during the immediate postoperative period.
All adverse events are continuously monitored and recorded by trained clinical staff using standardized observation procedures and behavioral scales (e.g., PAED scale for emergence delirium).
The observation period includes the entire post-anesthesia care unit stay until the child meets discharge criteria.
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From administration of study drug until discharge from the post-anesthesia care unit, assessed up to the maximum expected PACU stay (varies by individual, typically 1-4 hours)
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Emergence Time
Periodo de tiempo: In the post-anesthesia care unit on the day of surgery
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Time from discontinuation of anesthesia to emergence.
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In the post-anesthesia care unit on the day of surgery
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Postoperative Time to Discharge
Periodo de tiempo: From end of surgery to discharge on the day of surgery
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Time from the end of surgery to hospital discharge.
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From end of surgery to discharge on the day of surgery
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Parental Satisfaction Score Assessed by the Pediatric Anesthesia Parent Satisfaction (PAPS) Questionnaire
Periodo de tiempo: On the day of surgery before discharge
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Parental satisfaction with perioperative management assessed on the day of surgery before discharge using the Pediatric Anesthesia Parent Satisfaction (PAPS) questionnaire.
The questionnaire includes 15 items, and total scores range from 15 to 75, calculated as the sum of all item scores.
Higher scores indicate greater parental satisfaction.
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On the day of surgery before discharge
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: fei sun, Master's, Children's Hospital of Nanjing Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Procesos Patológicos
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Delirio
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Delirio de emergencia
- Desordenes mentales
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Preparaciones farmacéuticas
- Azoles
- Imidazoles
- Químicos inorgánicos
- Compuestos de cloro
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Compuestos de sodio
- Cloruros
- Ácido clorhídrico
- Esketamina
- Dexmedetomidina
- Solución salina
- Cloruro de sodio
Otros números de identificación del estudio
- 202512066-2
- SWYY2025002065 (Otro número de subvención/financiamiento: ISEFC, China)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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