Peri-Anesthetic Imaging of Cognitive Dysfunction (PAICOD)

This study is currently recruiting participants.
Verified January 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
James L. Blair, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01322672
First received: March 23, 2011
Last updated: January 29, 2014
Last verified: January 2014

March 23, 2011
January 29, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
Comparison of preoperative vs postoperative Brain MRI changes [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT01322672 on ClinicalTrials.gov Archive Site
Preoperative vs Postoperative Neurocognitive Testing [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
Not Provided
 
Peri-Anesthetic Imaging of Cognitive Dysfunction
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Postoperative Cognitive Dysfunction
  • Delirium
  • Dementia
  • Neurotoxicity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
January 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
65 Years to 95 Years
Yes
Contact: Damon R Michaels 615-343-6223 damon.michaels@vanderbilt.edu
Contact: Elizabeth Card 615-936-5354 elizabeth.card@vanderbilt.edu
United States
 
NCT01322672
IRB#100885
No
James L. Blair, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: James L Blair, DO Vanderbilt University
Vanderbilt University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP