Preoperative Dexmedetomidine & EC50 of Propofol (PreopDXM)
Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.
Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.
We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Seoul, Corea, república de, 110-799
- Seoul National University of Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery
Exclusion Criteria:
- Patients with an allergy to alpha-2 adrenergic agonists or propofol
- Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
- Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
- Patients with symptoms of upper respiratory infection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group D : Dexmedetomidine + propofol group
In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.
|
All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment. |
|
Comparador de placebos: Group C : Saline + propofol group
In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia.
|
All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EC50 of propofol required for successful i-gel insertion
Periodo de tiempo: During i-gel insertion anticipated up to 1 min
|
The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method.
The response of each patient determined the effect-site propofol concentration for the next patient.
If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1.
If the response was deemed a 'failure', the target concentration was increased by the same dose.
The process was repeated until the sixth crossover point (success/failure) was obtained.
|
During i-gel insertion anticipated up to 1 min
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the total dose of propofol infused before i-gel insertion
Periodo de tiempo: During i-gel insertion time anticipated upto 1min
|
The total amount of propofol infused before i-gel insertion was noted.
The insertion time, defined as the time from picking up the i-gel until the initiation of mechanical ventilation.
|
During i-gel insertion time anticipated upto 1min
|
|
the presence/severity of airway trauma after i-gel insertion
Periodo de tiempo: At the time point of removing the i-gel from patient's mouth
|
After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
|
At the time point of removing the i-gel from patient's mouth
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Hee Pyung Park, MD PhD, Professor
- Investigador principal: Young Cheol Kim, Md PhD, Professor
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Hipnóticos y sedantes
- Propofol
- Dexmedetomidina
Otros números de identificación del estudio
- PreopDXM_PPF
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. .