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Effect of Remifentanil Boluses on Hemodynamics in Skull Pin Insertion

25 janvier 2010 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Réel)

72

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation
Délai: 10 minutes
10 minutes

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2005

Achèvement primaire (Réel)

1 janvier 2010

Achèvement de l'étude (Réel)

1 janvier 2010

Dates d'inscription aux études

Première soumission

22 janvier 2010

Première soumission répondant aux critères de contrôle qualité

25 janvier 2010

Première publication (Estimation)

26 janvier 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 janvier 2010

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 janvier 2010

Dernière vérification

1 janvier 2010

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Insertion de la broche crânienne

Essais cliniques sur Remifentanil

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