Effect of Sedation on Cognitive Performance in the Elderly
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Hospital |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 1/27/2019 |
| Start Date: | March 2015 |
| End Date: | June 2019 |
Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)
The main goal of this study is to allow the anesthesiologist to make a more informed decision
about the anesthetic requirement of a person prior to starting anesthesia. The preliminary
data collected in this study will support a larger investigation aimed at gaining a better
understanding of anesthetic susceptibility in general and in the elderly population which
appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD)
POCD is a short-term decline in cognitive function (especially in memory and executive
functions) that may last from a few days to a few weeks after surgery. In rare cases, this
disorder may persist for several months after major surgery. POCD is distinct from emergence
delirium. It occurs most commonly in older patients and those with pre-existing cognitive
impairment. POCD is common in adult patients of all ages at hospital discharge after major
non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk
for long-term cognitive problems. The body's inflammatory response to surgery likely plays an
important role, at least in elderly patients. Investigators also postulate that a relative
'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better
judgment on the dose needed for an individual is extremely important.
about the anesthetic requirement of a person prior to starting anesthesia. The preliminary
data collected in this study will support a larger investigation aimed at gaining a better
understanding of anesthetic susceptibility in general and in the elderly population which
appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD)
POCD is a short-term decline in cognitive function (especially in memory and executive
functions) that may last from a few days to a few weeks after surgery. In rare cases, this
disorder may persist for several months after major surgery. POCD is distinct from emergence
delirium. It occurs most commonly in older patients and those with pre-existing cognitive
impairment. POCD is common in adult patients of all ages at hospital discharge after major
non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk
for long-term cognitive problems. The body's inflammatory response to surgery likely plays an
important role, at least in elderly patients. Investigators also postulate that a relative
'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better
judgment on the dose needed for an individual is extremely important.
Central nervous system (CNS) function is affected by sedation and anesthesia. This is evident
from the desired clinical effects of sedative and anesthetic drugs. Recent evidence suggests
that disruption CNS function may be prolonged and result in unwanted cognitive effects in
predisposed individuals. Investigators know that there is a considerable pharmacokinetic
(onset, distribution and elimination) and pharmacokinetic variability of neurotropic drugs
even with in persons within a certain age and weight group. What the investigators do not
know, is how to predict or quantify an individual's susceptibility to sedation and anesthesia
and, more importantly, the potential cognitive susceptibility of an individual's brain to
these drugs.
Auditory functional imaging is a well validated task. It can be applied as a short (5 minute)
test. Investigators know (preliminary data) that the size of the brain activation area
changes after sedation. Investigators now postulate that this change reflects a disruption of
neuronal integration in the brain and that this change may be an objective measure of the
cognitive effects of sedation for an individual.
As supportive data for an R-01 grant application the investigators propose to enroll 20
elderly subjects by public advertisement and quantify the effects of sedation with midazolam
on auditory activation (auditory fMRI) and cognitive performance (mini Mental State exam and
complex reaction time).
from the desired clinical effects of sedative and anesthetic drugs. Recent evidence suggests
that disruption CNS function may be prolonged and result in unwanted cognitive effects in
predisposed individuals. Investigators know that there is a considerable pharmacokinetic
(onset, distribution and elimination) and pharmacokinetic variability of neurotropic drugs
even with in persons within a certain age and weight group. What the investigators do not
know, is how to predict or quantify an individual's susceptibility to sedation and anesthesia
and, more importantly, the potential cognitive susceptibility of an individual's brain to
these drugs.
Auditory functional imaging is a well validated task. It can be applied as a short (5 minute)
test. Investigators know (preliminary data) that the size of the brain activation area
changes after sedation. Investigators now postulate that this change reflects a disruption of
neuronal integration in the brain and that this change may be an objective measure of the
cognitive effects of sedation for an individual.
As supportive data for an R-01 grant application the investigators propose to enroll 20
elderly subjects by public advertisement and quantify the effects of sedation with midazolam
on auditory activation (auditory fMRI) and cognitive performance (mini Mental State exam and
complex reaction time).
Inclusion Criteria:
- Must be a healthy subject
- 55 years and older
- Able to follow study instructions.
Exclusion Criteria:
- Obesity (BMI > 35)
- Non-English speaking/reading
- Sleep apnea
- Moderate to severe bronchial asthma
- Cardiovascular problems including hypertension
- History of claustrophobia
- Presence of a pacemaker,
- Defibrillator,
- Any surgically placed metallic object,
- Presence of bullet or shrapnel in the body,
- Presence of a non-removable prosthetic,
- Use of a hearing aid if unable to hear otherwise,
- Head girth exceeding that of the head coil used in the MRI
- Extensive metal work on or in teeth
- Non-removable dentures or bridgework, epilepsy
- Chronic pain medication use/abuse
- Excessive tattoos (local skin heating can occur with tattoos containing ferromagnetic
particles)
- History of surgery for which the details are unavailable
- Allergy to Midazolam
- History of drug abuse
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