Peri-Anesthetic Imaging of Cognitive Dysfunction
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - 95 |
| Updated: | 2/7/2019 |
| Start Date: | March 2011 |
| End Date: | August 27, 2015 |
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.
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.
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.
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.
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
We found this trial at
2
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials