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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01269918
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)
26 de octubre de 2016 actualizado por: The Cleveland Clinic
This will be a randomized blinded clinical trial.
Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia.
The anesthesia team will know the result of randomization at induction.
Data will be gathered by research personnel who will be blinded to the anesthetic method used.
Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded.
The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Anesthesia for craniotomy presents a unique challenge to the anesthesiologist.
Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics.
(1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia.
At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation.
Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain.
(2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain.
(2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
142
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
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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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
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:
- Age: Older than 18
- Primary and redo cases will be included
- Duration of surgery not exceeding 6 hrs.
Exclusion Criteria:
- Patient refusal
- Emergency craniotomy
- Morbid obesity
- Uncontrolled hypertension - DBP more than 110
- Cardiac conduction defects
- Patients with chronic pain.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Remifentanil
Remifentanil 0.08-0.15MCG/KG/MIN
INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
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Remifentanil 0.08-0.15MCG/KG/MIN
INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Otros nombres:
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Comparador activo: Dexmedetomidine
a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
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a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hemodynamics
Periodo de tiempo: 15, 30, 45, 60, and 90 minutes after extubation.
|
Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg).
This outcome was analyzed using a repeated measures ANOVA approach.
In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.
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15, 30, 45, 60, and 90 minutes after extubation.
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Postoperative Pain
Periodo de tiempo: 15, 30, 45, 60, and 90 minutes after extubation.
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Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable.
This outcome was analyzed using a repeated measures ANOVA approach.
In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.
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15, 30, 45, 60, and 90 minutes after extubation.
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Total Opioid Consumption
Periodo de tiempo: Initial 90 minutes of recover after surgery
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Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.
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Initial 90 minutes of recover after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Heart Rate
Periodo de tiempo: 15, 30, 45, 60, and 90 minutes after extubation.
|
Heart rate was determined from the arterial catheter and measured as beats per minute.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Modified Short Orientation Memory Concentration Test (SOMCT)
Periodo de tiempo: 15, 30, 45, 60, and 90 minutes after extubation.
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The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits.
SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function).
Scores > 20 are considered normal.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Aldrete Score
Periodo de tiempo: 15, 30, 45, 60, and 90 minutes after extubation.
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The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit.
The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness.
This outcome was analyzed using a repeated measures ANOVA approach.
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15, 30, 45, 60, and 90 minutes after extubation.
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Nursing Workload Comparison
Periodo de tiempo: 90 minutes after extubation
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To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system.
This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).
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90 minutes after extubation
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Drug Stop Time to Open Eyes
Periodo de tiempo: Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
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time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery
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Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
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Drug Stop Time to Recall
Periodo de tiempo: Time between extubation until patients could say their names.
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Time between extubation until patients could say their names.
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Time between extubation until patients could say their names.
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Drug Stop Time to Fitness to Discharge
Periodo de tiempo: Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
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Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
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End Case to Post Anesthesia Care Unit (PACU) Discharge
Periodo de tiempo: End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
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Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU.
This outcome is the amount of time (minutes) from end case to PACU discharge.
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End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
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Postoperative Nausea
Periodo de tiempo: Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had nausea or not
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Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
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Postoperative Vomitting
Periodo de tiempo: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had postoperative vomiting.
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Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
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Postoperative Shivering
Periodo de tiempo: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
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Indicator of whether patients had postoperative shivering.
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Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shobana Rajan, MD, The Cleveland Clinic
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 julio de 2011
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
22 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
3 de enero de 2011
Publicado por primera vez (Estimar)
4 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Dolor Postoperatorio
- 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
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Analgésicos Opiáceos
- Estupefacientes
- Hipnóticos y sedantes
- Remifentanilo
- Dexmedetomidina
Otros números de identificación del estudio
- 10-1056
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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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