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Peri-Anesthetic Imaging of Cognitive Dysfunction (PAICOD)

3 de febrero de 2019 actualizado por: James L. Blair, Vanderbilt University

Peri-Anesthetic Imaging Compared With Neurocognitive Testing: A Pilot Study

Recent data suggests that anesthetics can have prolonged effects on gene expression, protein synthesis and processing as well as cellular function in ways that the investigators are only beginning to understand, especially in the very young and the elderly. Within moments to days of emerging from anesthesia - cardiac or non-cardiac - some patients experience mild to very severe disorientation and changes in memory and thinking ability without apparent cause. For the vast majority of patients, this Post-Operative Cognitive Dysfunction (POCD), generally subsides, but for some with "diminished cognitive reserve" - especially the elderly, those with less education or prior CNS events such as stroke or early dementia - changes in memory and executive function may persist. If prolonged for more than three months, POCD has been linked to an increased risk of death. In 1-2% of elderly patients, the problem may ultimately continue for more than a year, leading to a loss of ability to care for themselves and early demise. Though this may seem like a small percentage, seniors will comprise up to 40% of the 50-75 million surgical procedures performed annually over the next 20-30 years. This amounts to 70,000 - 200,000 elder affected, and for them and their families, the cost of POCD in longer-term care, lost wages, and extended suffering will remain very high.

Descripción general del estudio

Descripción detallada

For more than 160 years, "modern" anesthesia has provided immense benefit to patients of all ages. However, over the past several years, concern has been growing that for patients at the extremes of age, some anesthetic agents may harbor subtle, previously minimally examined, serious neurotoxic effects which can cause lasting decline in the function of the central nervous system (CNS). For the elderly, these effects may manifest in lasting post-operative deterioration of memory and the capacity for normal information processing that can result in the inability to perform the activities of daily living (ADLs) with eventual early demise. Unfortunately, even though our ability to evaluate anesthetic risk has grown asymptotically for virtually every organ system, the brain remains neglected. And even though we know a good deal about effect sites for general anesthetic agents, we still have an incomplete understanding of the potential toxic effects of anesthetics on the brain. Therefore, employing a human surgical model (endoscopic prostatectomy), we propose a pilot study of 15 otherwise neurologically intact, ASA I - III, males, 65+ year of age. After pre-enrollment screening (MMSE & BDI) and standard pre-op evaluation, subjects will undergo both anatomic and functional MRI studies plus a battery of neurocognitive tests (NCT) at two time points approximately 2-3 weeks apart prior to surgery. These pre-op studies will establish both a "non-surgical control" for the study as well as a baseline for post-op studies. 2-3 weeks after surgery, MRI and NCT will be repeated. The study aims to determine if MRI can demonstrate changes in the CNS pre-op vs post-op that relate to anesthesia and surgery and how those changes might correlate with NCT over the same interval.

Tipo de estudio

De observación

Inscripción (Actual)

6

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

    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center

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

65 años a 95 años (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Subjects will be non-rheumatoid, non-immune-compromised, males and females, 65+ years old, scheduled for open abdominal surgery under general anesthesia of 3+ hour's duration.

Descripción

Inclusion Criteria:

  • Age 65+ years; ASA I - III; capable and willing to consent
  • Scheduled for 3+ hour Endoscopic Prostatectomy under general anesthesia
  • Baseline MMSE > 20 (exclude dementia)
  • All suitable for MRI testing

Exclusion Criteria:

  • Hx Autoimmune Disease
  • Severe visual or auditory disorder/handicaps
  • Unable to read or understand English
  • Pre-existing cognitive impairment; e.g., MS, AD or Parkinson's Disease, etc.
  • Patients not expected to be able to complete the 2-3 week postoperative testing
  • Major psychiatric condition such as bipolar disorder, schizophrenia
  • Severe Panic Disorder
  • Any implanted ferrous metal

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Comparison of preoperative vs postoperative Brain MRI changes
Periodo de tiempo: 2 months
Anesthetics can have prolonged effects on gene expression, protein synthesis and processing as well as cellular function, especially in the very young and the elderly. After anesthesia, some patients experience mild to very severe disorientation and even delirium without apparent cause. In the elderly, this Post-Operative Cognitive Dysfunction (POCD) - including changes in memory and executive function may persist and has been linked to an increased risk of death. Over the next 20-30 years, 40% of 65+ year-olds will undergo surgery; the cost of POCD in longer-term care, lost wages, and extended suffering of patients and families will remain high.
2 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Preoperative vs Postoperative Neurocognitive Testing
Periodo de tiempo: 2 Months
Pre- vs postoperative Neurocognitive Testing (NCT) is currently the primary method used to quantify changes in cognitive indices, including memory, processing speed, motor function, etc. This study will compare such pre- and post-op NCT with pre-and post-op MRI and fMRI to determine relationships between changes in each of these modalities.
2 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: James L Blair, DO, Vanderbilt University Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Actual)

1 de marzo de 2011

Finalización primaria (Actual)

27 de agosto de 2015

Finalización del estudio (Actual)

27 de agosto de 2015

Fechas de registro del estudio

Enviado por primera vez

23 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

23 de marzo de 2011

Publicado por primera vez (Estimar)

24 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de febrero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

3 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

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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