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Effect of Remifentanil Boluses on Hemodynamics in Skull Pin Insertion

25 de enero de 2010 actualizado por: University Health Network, Toronto

The Dose Effects of Remifentanil Boluses on the Hemodynamic Response to Skull Pin Insertion.

Skull pin insertion during craniotomies is a brief, intensely stimulating, painful stimuli occurring during the conduct of a neurosurgical or spine anesthetic. Remifentanil is an ultra short acting opioid that has been successfully used to blunt hemodynamic responses in a wide variety of clinical scenarios. It is our intention to ascertain the optimal dose for blunting the hemodynamic response to skull pin insertion using remifentanil.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Skull pin insertion is commonly required for craniotomies and cervical spine surgery. It is a brief but highly stimulating maneuver performed following induction, during a period of light anesthesia, and may cause significant rise in blood pressure, heart rate and intracranial pressure if not anticipated and treated.

A wide variety of methods have been shown to be effective at blunting this hypertensive response. These include intravenous agents such as fentanyl, sufentanil, clonidine, ketamine and magnesium sulphate, local anesthetic methods such as injection at pin sites or full scalp blocks, deepening the volatile agent, oral premedication or a combination of these methods. There is no consensus on which of these methods is the best. Many anesthesiologists simply use boluses of propofol - a reliable way of accomplishing this effect with a familiar drug. It is also very common for anesthesiologists to use remifentanil, by increasing the infusion rate and or bolusing.

Remifentanil is an ultra-short acting opiate with such rapid onset and offset, that it is most easily and safely delivered by infusion. Increasingly in the literature, however, are reports of remifentanil administered as boluses rather than infusions. Boluses may be ideal for very short stimulating procedures such as intubation and skull pin fixation where a quick onset and offset are desired. Although the safety of bolusing remifentanil has been established in many studies , some authors are still apprehensive . Care must be taken to avoid bolusing with greater doses than required since this may lead to bradycardia and hypotension. In non-ventilated patients, respiratory depression is common and chest wall rigidity may occur at doses larger than 4ug/kg9.

Different bolus dose-effect studies have recommended the following for remifentanil in a variety of clinical settings:

  • 3-5ug/kg with propofol 2mg/kg for intubation without muscle relaxants ,
  • 2ug/kg with propofol TCI (>4ug/ml) and cisatracurium for intubation (no additional hemodynamic benefit using 4ug/kg)
  • 1-1.25ug/kg for rapid sequence intubation with thiopentone 5-7mg/kg and succinylcholine 1mg/kg
  • ED50 of 1.7ug/kg and ED95 of 2.88ug/kg for good to excellent intubating conditions in both infants and children (when used with 10ug/kg glycopyrrolate and 4mg/kg propofol)
  • 3ug/kg (plus 4mg/kg propofol) provides similar intubating conditions when used in place of succinylcholine 2mg/kg for intubation in infants8

Remifentanil is not currently recommended for the following settings:

  • As a sole agent for loss of consciousness with a high ED50 of 12ug/kg, lack of reliability and muscle rigidity common at such high doses
  • Wide interindividual variability limit its use for labor analgesia (0.2-0.8ug/kg, median dose of 0.4ug/kg)

In neurosurgery, it is common to administer remifentanil as an infusion. Optimal infusion rates have already been investigated for intracranial surgery . However it is increasingly common to administer remifentanil as a bolus particularly during skull pin fixation, due to the desirable quick onset and offset, and there are no studies at present that have investigated optimal dose requirements for boluses in this setting.

At our institution we commonly administer remifentanil as a bolus during skull pin fixation and are interested in determining which bolus doses are safe and effective

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ontario
      • Toronto, Ontario, Canadá, M5T 2S8
        • Toronto Western Hospital

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

20 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Patients requiring skull pin fixation and general anesthesia for:

  • Elective cervical spine surgery
  • Elective craniotomies/brain tumor resection
  • Elective transsphenoidal pituitary hypophysectomies

Exclusion Criteria:

Patients with evidence of raised intracranial pressure:

  • GSC < 15
  • Radiological evidence of significant rise in ICP (e.g. midline shift)
  • Vascular anomalies in the brain

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1.25 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.5 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.75 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.75 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1 ug/kg normo-tensive 65-75 year olds
A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.25 ug/kg normo-tensive 65-75 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.5 ug/kg normo-tensive 65-75 year olds

1.5 ug/kg normo-tensive 65-75 year olds

A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.

A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.25 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
Experimental: 1.5 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation
Periodo de tiempo: 10 minutes
10 minutes

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
To determine the optimal doses for remifentanil in order to blunt the hemodynamic changes associated with skull pin fixation
Periodo de tiempo: 10 minutes
10 minutes
to assess variability in dose requirements of remifentanil
Periodo de tiempo: 10 minutes
10 minutes
to compare the dose effects in younger (20-40yo) vs. older (65-75yo) age groups
Periodo de tiempo: 10 minutes
10 minutes
to compare the dose effects in older (65-75yo) age groups in hypertensive versus non-hypertensive patients
Periodo de tiempo: 10 minutes
10 minutes

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Atul Prabhu, MD, University Health Network, Toronto

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

1 de mayo de 2005

Finalización primaria (Actual)

1 de enero de 2010

Finalización del estudio (Actual)

1 de enero de 2010

Fechas de registro del estudio

Enviado por primera vez

22 de enero de 2010

Primero enviado que cumplió con los criterios de control de calidad

25 de enero de 2010

Publicado por primera vez (Estimar)

26 de enero de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de enero de 2010

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

25 de enero de 2010

Última verificación

1 de enero de 2010

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. .

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