- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02733406
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Östersund, Alberta, Suecia, 83183
- Östersund 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:
* 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 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 |
|---|---|
|
Otro: 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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Otro: Velocity Controlled Infusion
This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hypotension
Periodo de tiempo: 20 minutes
|
Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)
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20 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacological measures to increase blood pressure
Periodo de tiempo: 20 minutes
|
Number of doses of drug to increase blood pressure
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20 minutes
|
|
Drug consumption
Periodo de tiempo: 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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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)
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
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 (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
- TCI hypotension TIVA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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