Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion in Children
Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion Anesthesia for One Day Surgery in Pediatric Patients
Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension.
All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prospective, randomized controlled study will be done at the University Children's Clinic. For the study ethical board approval was requested. Pediatric patients, planned for elective, one day surgery, requiring intubation with signed informed consent will be randomly assigned to two groups First in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group).
All participants will be premedicated half an hour before anesthesia induction with midazolam orally in dose of 0.5mg/kg body weight. Intravenous cannula will be placed 20-30 minutes later, and participants will receive atropine in dose of 0,02mg/kg intravenously, and fentanyl 1mcg/kg intravenously. In the MC group participants will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance will be done according to the Mc Farlan scheme. In TC group Pedfusor model will be used, with target concentration for anesthesia induction of 4 mcg/kg body weight and anesthesia maintenance of 3 mcg/kg. In all participants remifentanil in dose of 0.4mcg/kg/min will be used as analgesic, and cisatracurium 0.15mg/kg was muscle relaxant, for anesthesia induction. At the end of surgery, before remifentanil infusion is stopped, all patients will receive 0.5 mg/kg of ketorolac. If BIS values are out of the40-60 range during anesthesia, in MC group infusion rate will be changed and in TC group set plasma concentration (Cp) will be corrected. In case of heart rate increase or decrease for more than 20% compared to initial values, speed of remifentanil infusion will be decreased or increased, respectively. All participants will have standard monitoring during anesthesia: percutaneous saturation, end tidal concentration of carbon dioxide measurement, three channel electrocardiography, noninvasive blood pressure monitoring, and continuous BIS measurement. Propofol infusion will be stopped 5 minutes before expected end of surgery, and remifentanil infusion will be stopped at the end of surgery. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Belgrade, Serbia, 11000
- University Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA score 1 and 2.
- Planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery,
- Signed written informed consent for participation in the study by parent and/or legal guardian.
Exclusion Criteria:
- Confirmed propofol allergies.
- Mitochondrial disease
- Disease of lipid and carbohydrate metabolism
- Neurological disorders
- Treated psychiatric comorbidities
- Hypertension.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Manually controlled
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Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.
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Experimental: Target controlled
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Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depth of anesthesia comparison between two experimental groups.
Periodo de tiempo: From anesthesia induction till extubation, every minute up to 90 minutes.
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Depth of anesthesia will be measured with continuous bispectral index and compared between two experimental groups.
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From anesthesia induction till extubation, every minute up to 90 minutes.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of blood pressure between two experimental groups.
Periodo de tiempo: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
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Blood pressure will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
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At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
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Comparison of heart rate between two experimental groups.
Periodo de tiempo: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
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Heart rate will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
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At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
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Time to tracheal extubation comparison between two experimental groups.
Periodo de tiempo: 5 to 15 minutes after discontinuation of propofol infusion
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Time to tracheal extubation will be measured after propofol infusion termination in both experimental groups and compared.
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5 to 15 minutes after discontinuation of propofol infusion
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TirsovaChildrensH
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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