- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01377623
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Surgical injury to tissue causes a variety of profound physiologic reactions which are essential for the restoration of an organisms' homeostasis. The inflammatory response involves a surge of stress hormones (i.e. ACTH, cortisol, catecholamines), activation of the complement system, migration of leukocytes to the site of injury, the release of cytokines (i.e. interleukins, tumor necrosis factor), as well as other cellular products (i.e. superoxide radicals, proteases, growth factors) (1-3). An appropriate inflammatory cascade is essential for tissue reconstitution and infection control. The associated impairment of multiple organ function is generally mild, because of the physiological reserve of the biological systems. However, a systemic inflammatory response may also lead to postoperative complications in the elderly, neonates, and patients with significant co-morbidity (4, 5). Indeed, mediators of inflammation may induce fatigue and prolong convalescence in healthy patients. On the other hand, dysregulation or suppression of the inflammatory process may lead to improper wound healing, infection and, as demonstrated recently, even an increase in cancer recurrence due to reduction in natural killer cell activity (6, 7).
Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms either directly by modulating functions of immune cells or indirectly by attenuating the stress response. For example, inhalational anesthetics inhibit neutrophil function and depress lymphocyte proliferation while increasing pro-inflammatory cytokine levels (8, 9)). Propofol also inhibits neutrophil and monocyte function, and has strong anti-inflammatory and anti-oxidative effects (10). Opioids attenuate the direct cell immune response, but have only minimal effects on systemic inflammatory responses (11). It is expected that the choice of anesthetic technique may disturb the balance between pro- and anti-inflammatory responses thus affecting clinical outcomes. A most advantageous anesthetic choice would enhance or have a neutral effect on cellular immunity while minimizing contribution to the systemic inflammatory response.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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New York, New York, Estados Unidos, 10016
- NYU Langone Medical Center, Department of Anesthesiology
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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:
- Adult (> 18) male or female who will undergo surgery for spinal fusion with general anesthesia.
If female, subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
- Subject is ASA physical status 1, 2, or 3.
Exclusion Criteria:
- Cognitively impaired (by history)
- Subject requires chronic antipsychotic history
- Subject is anticipated to require an additional surgery within 90 days after the intended spinal fusion
- Subject known to be in liver failure
- Subject has received treatment with alpha-2-agonist or antagonist within 2 weeks of study entry
- Subject for whom opiates, benzodiazepines, DEX are contraindicated
- Chronic use of steroids/NSAIDs
- Patients with serious bradycardia related arrhythmias, i.e. 2nd degree block.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo group
Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
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Fifty six subjects (28 in each arm) will be enrolled.
Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study.
Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery.
Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
|
Experimental: Dexmedetomidine group
Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
|
Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study.
Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery.
Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of Recovery Score (QoR-40)
Periodo de tiempo: Post-operative Day 3
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The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5.
QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
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Post-operative Day 3
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Concentration of TNF-alpha
Periodo de tiempo: Post-operative Day 1
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Post-operative Day 1
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Concentration of IL-1a
Periodo de tiempo: Post-operative Day 1
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Post-operative Day 1
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Concentration of IL-6
Periodo de tiempo: Post-operative Day 1
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Post-operative Day 1
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Concentration of IL-8
Periodo de tiempo: Post-operative Day 1
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Post-operative Day 1
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Urban, MD, Hospital for Special Surgery, New York
Publicaciones y enlaces útiles
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
- Procesos Patológicos
- Enfermedades musculoesqueléticas
- Enfermedades de la columna
- Enfermedades óseas
- Inflamación
- Estenosis espinal
- 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
- Hipnóticos y sedantes
- Dexmedetomidina
Otros números de identificación del estudio
- 10-02185
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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