Hypotensive Effect of Anaesthesia With TCI (HEAT)
The Effect of Target Controlled Infusion as Opposed to Velocity Controlled Infusion on Hypotension at Induction of Total Intravenous Anaesthesia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Severe hypotension may be a serious complication to induction of anaesthesia. The patients preoperative clinical circulatory status will help define the risks of such a side-effect. A patient with a preexisting heart condition will be at increased risk for morbidity/mortality in relation to anaesthesia induction.
Total intravenous anaesthesia may be delivered by two different approaches. The old way where the drug (Propofol and/or Remifentanil) is delivered in a velocity (mg/kg x hour or microg/ kg x min) specified by the anaesthetist. Hereafter called Velocity Controlled Infusion (VCI). At induction, to get effect of the drug, a high infusion rate is desired. A high infusion rate is associated with increased risks of hypotension if it is not adjusted in accordance with the current circulatory status of the patient. A failure to adjust may be futile for the patient. Therefore, induction takes some time because infusion rate is set within a relatively safe range. After a few minutes, once airway control is achieved, the infusion rate must be adjusted down to avoid hypotension.
There is a more modern way of adjusting the infusion rate, the so called Target Controlled Infusion. With this approach, the pump delivering the drug will help the anaesthetist to select the appropriate infusion rate for any given situation. The anaesthetist selects a preferred concentration of the drug at the target, that is in the circulation. The pump then administrates the drug, first at high rate and then at lower rate, taking into account the patients age, weight and sex and the preferred target concentration.
It is possible that this help from the machine is associated with less risk for hypotension at anaesthesia induction. If this is so it would have an impact on which of TCI and VCI that would be the best choice of anaesthesia. This would have special impact when giving anaesthesia to patients with a heart condition.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alberta
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Östersund, Alberta, Suède, 83183
- Östersund Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
* All patients scheduled for anaesthesia at Östersunds Hospital
- ASA class I-II
Exclusion Criteria:
- On beforehand decision to start continous delivery of blood pressure increasing drug at induction.
- Any contraindication to Total Intravenous Anaesthesia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Target Controlled Infusion
This group of patients will have their anaesthesia induced with Target Controlled Infusion (TCI)
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|
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Autre: Velocity Controlled Infusion
This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hypotension
Délai: 20 minutes
|
Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)
|
20 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pharmacological measures to increase blood pressure
Délai: 20 minutes
|
Number of doses of drug to increase blood pressure
|
20 minutes
|
|
Drug consumption
Délai: From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).
|
Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered.
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From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).
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|
PONV (Postoperative Nausea and Vomiting)
Délai: From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit
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Dose and name of any drug given to reduce PONV at any time defined above (in addition to profylaxis with the same aim)
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From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TCI hypotension TIVA
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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