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- Ensayo clínico NCT03134547
A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After approval Institutional Review Board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. By a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (Group LS) or the high dose (2.5%) end tidal concentration of sevoflurane group (Group HS). The patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. Then the patients were into the operating room, applied electrocardiography (ECG), pulse oximetry, and noninvasive blood pressure. Respiratory rate and end tidal carbon dioxide (CO2) were monitored via face mask. After baseline vital signs were monitored, the patient was posed in lateral Sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 G needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. All of these procedures were performed by one skilled anesthesiologist who blinded about the study group. After caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. If oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. If analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly.
In the postanesthetic care unit (PACU), the investigators observed EA episodes at 5 and 30 min after PACU arrival using Four-point agitation scale and Pediatric Anesthesia Emergence Delirium (PAED) scale, and if a total score of PAED scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. EA was considered as an Four-point agitation scale > 3 or PAED scale > 10.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1
Exclusion Criteria:
- Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: low volume volatile anesthetics
1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
|
low volume volatile anesthetics (1.0%)
Otros nombres:
|
Comparador activo: high volume volatile anesthetics
2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
|
high volume volatile anesthetics (2.5%)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
postoperative agitation score
Periodo de tiempo: 5 minutes in the recovery room
|
Four-point agitation scale
|
5 minutes in the recovery room
|
postoperative agitation score
Periodo de tiempo: 30 minutes in the recovery room
|
Four-point agitation scale
|
30 minutes in the recovery room
|
postoperative agitation score
Periodo de tiempo: 5 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
5 minutes in the recovery room
|
postoperative agitation score
Periodo de tiempo: 30 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
30 minutes in the recovery room
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eun kyung Choi, MD,PhD, Yeungnam University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Desordenes mentales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Manifestaciones neurológicas
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Discinesias
- Trastornos psicomotores
- Delirio
- Agitación psicomotora
- Delirio de emergencia
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Anestésicos Generales
- Anestésicos
- Inhibidores de la agregación plaquetaria
- Anestésicos, Inhalación
- Sevoflurano
Otros números de identificación del estudio
- YUMC 2017-04-12
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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