Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Recovery Trajectories After Propofol-Based Intravenous Anesthesia in Toddlers and Older Children

11 de agosto de 2026 actualizado por: Mariam Ashraf Salah Ali, Assiut University

Age-Stratified Recovery Trajectories Following Propofol-Based Total Intravenous Anesthesia: A Comparative Study Between Toddlers (3-6 Years) and Older Children (6-12 Years)

This observational study aims to compare how quickly and smoothly younger children (ages 3 to 6 years) recover from general anesthesia compared to older children (ages 6 to 12 years).

While inhalational anesthesia (breathing in anesthetic gases) has traditionally been the standard for pediatric surgeries, total intravenous anesthesia (TIVA) using a short-acting medication called propofol is increasingly being used. Propofol TIVA offers several benefits, including reduced postoperative nausea and vomiting, less airway irritation, a smoother waking process, and an earlier readiness to go home. However, because children's bodies and metabolisms change rapidly as they grow, the way propofol is processed by and clears from the body varies significantly by age.

Currently, there is limited evidence detailing exactly how these age-related differences affect recovery times. To investigate this, researchers will monitor 64 children undergoing elective surgeries (lasting between 30 and 120 minutes) who receive propofol TIVA as their primary anesthetic.

After the procedure, the study will measure the exact time it takes for participants in both age groups to meet specific, standardized safe-discharge criteria (known as Phase II recovery readiness). Researchers will also track several other important recovery factors, including the time it takes for children to open their eyes, pain levels, the occurrence of emergence delirium (agitation or confusion upon waking), and any breathing-related complications. By comparing the recovery trajectories of toddlers and older children, this research seeks to improve postoperative care planning and provide clearer expectations for pediatric intravenous anesthesia.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

64

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of pediatric patients aged 3 to 12 years with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for elective surgical procedures at Assiut University Hospitals. Eligible participants are those anticipated to have a surgical duration between 30 and 120 minutes and who receive propofol-based total intravenous anesthesia (TIVA) as their primary anesthetic technique. Patients are excluded from the population if they present with neurological disorders, developmental delay, hepatic or renal impairment, obesity (greater than the 95th percentile), or if they are taking concomitant sedative medications.

Descripción

Inclusion Criteria:

  • Age 3-12 years
  • ASA I-II
  • Elective surgery under general anaesthesia
  • Surgical duration 30-120 minutes
  • Propofol TIVA as the primary anesthetic technique

Exclusion Criteria:

  • Neurological disorders
  • Developmental delay
  • Hepatic or renal impairment
  • Obesity (>95th percentile)
  • Concomitant sedative medications

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Toddlers (3-6 years)
Pediatric patients aged 3 to 6 years undergoing elective surgery under general anesthesia. This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.
Older Children (6-12 years)
Pediatric patients aged 6 to 12 years undergoing elective surgery under general anesthesia. This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Achieve Fast-Track Phase II Recovery Readiness
Periodo de tiempo: 2 hours post-surgery
The time elapsed in minutes from the end of surgery (defined as the placement of the last stitch) until the patient achieves Phase II recovery readiness. Readiness is determined using the White Fast-Track Score, which requires patients to achieve a total score of 12 or greater with no individual component scoring less than 1.
2 hours post-surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de agosto de 2026

Publicado por primera vez (Actual)

14 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir