Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery (ERAS-MALTO)
Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery: A Pilot Randomized Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Enhanced Recovery After Surgery (ERAS) protocols are multidisciplinary perioperative care programs developed to reduce surgical stress, improve postoperative recovery, and shorten hospital stay. In adult surgical populations, preoperative administration of carbohydrate-rich clear fluids has been associated with reduced insulin resistance, improved metabolic response, reduced postoperative nausea, and improved patient comfort.
Evidence regarding the use of these strategies in pediatric surgical patients remains limited. This prospective randomized controlled no-profit pilot study aims to evaluate the clinical impact of preoperative maltodextrin administration in children undergoing elective surgery.
Approximately 200 pediatric patients aged 3 to 8 years undergoing elective day surgery at the Pediatric Surgery Unit of the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria will be enrolled. Participants will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid two hours before surgery.
Primary outcome evaluation includes preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). Secondary outcomes include parental anxiety, oxidative stress markers, postoperative feeding tolerance, postoperative vomiting, postoperative pain evaluation, and discharge eligibility after surgery.
Clinical, demographic, laboratory, anesthesiologic, and perioperative data will be collected and analyzed to assess the feasibility and effectiveness of this ERAS-based intervention in pediatric surgical patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Trial Center
- Número de teléfono: 0131206893
- Correo electrónico: clinicaltrialcenter@ospedale.al.it
Ubicaciones de estudio
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Piedmont
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Alessandria, Piedmont, Italia, 15121
- Reclutamiento
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
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Contacto:
- Pediatric Surgery Unit Clinical Trial Center
- Número de teléfono: 0131206893
- Correo electrónico: clinicaltrialcenter@ospedale.al.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pediatric patients aged 3 to 17 years
- Patients undergoing elective surgery in a day surgery setting
- Surgical procedure duration less than 60 minutes
- Written informed consent signed by a parent or legal guardian
Exclusion Criteria:
- Maltodextrin intake within 3 hours before surgery
- Allergy or intolerance to maltodextrins
- Diabetes mellitus or other metabolic disorders potentially affecting study variables
- Inadequate nutritional status based on body mass index (BMI)
- Absence of signed informed consent by parent or legal guardian
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Maltodextrin Group
Pediatric patients receiving 125 mL of a clear liquid containing maltodextrins two hours before elective surgery as part of the ERAS preoperative fasting protocol.
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Administration of 125 mL of a clear liquid containing maltodextrins two hours before elective pediatric surgery as part of the ERAS preoperative fasting protocol.
Otros nombres:
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Comparador de placebos: Control Group
Pediatric patients receiving 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective surgery.
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Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
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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Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Periodo de tiempo: 20 to 30 minutes before surgery
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Evaluation of preoperative anxiety and agitation in pediatric surgical patients receiving maltodextrin-containing clear liquids compared with control patients receiving non-sugared clear liquids before elective surgery.
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20 to 30 minutes before surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative pain assessed by Visual Analogue Scale (VAS)
Periodo de tiempo: 2 hours after surgery
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Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery.
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2 hours after surgery
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Eligibility for discharge after surgery
Periodo de tiempo: 6 hours after surgery
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Evaluation of the proportion of pediatric patients considered eligible for discharge 6 hours after elective surgery according to postoperative recovery and clinical conditions.
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6 hours after surgery
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Evaluation of postoperative vomiting
Periodo de tiempo: Within 6 hours after surgery
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Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.
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Within 6 hours after surgery
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Preoperative oxidative stress
Periodo de tiempo: Immediately before surgery
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Blood chemistry tests for the assessment of preoperative stress
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Immediately before surgery
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Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)
Periodo de tiempo: Immediate preoperative period
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Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery
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Immediate preoperative period
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Evaluation of postoperative oral feeding tolerance
Periodo de tiempo: Within 6 hours after surgery
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Oral feeding tolerance will be assessed by the ability to tolerate the first oral intake without vomiting or need to interrupt feeding.
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Within 6 hours after surgery
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Desordenes mentales
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Hiperinsulinismo
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Comportamiento de alimentación
- Desórdenes de ansiedad
- Resistencia a la insulina
- Ayuno
- Terapéutica
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Fenómenos fisiológicos nutricionales
- Terapia de dieta
- Terapia nutricional
- Dieta
- Dieta, Carga de Carbohidratos
Otros números de identificación del estudio
- ASO.ChirPed.24.05
Plan de datos de participantes individuales (IPD)
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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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