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Effect of Sedation on Cognitive Performance in the Elderly

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ClinicalTrials.gov Identifier: NCT03089866
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Postoperative Cognitive Dysfunction Drug: Midazolam (0.02mg/kg)

Detailed Description:

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).

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)
Actual Study Start Date : March 2015
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ASA Patients I or II
Participants are healthy (BMI <35), 55years and older, and have the ability to follow instructions. In this population we will quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).
 Drug: Midazolam (0.02mg/kg)
Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).


Outcome Measures
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Primary Outcome Measures :
  1. Effect of a single dose of midazolam on cognitive function. [ Time Frame: Baseline to 1hour ]
    Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores before and after sedation

  2. Effect of a single dose of Midazolam on Auditory Activation [ Time Frame: Baseline to 1 hour ]
    Change in Brain activation before and after sedation


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants classified by the American Society of Anesthesiologists (ASA) as a Class I or II patient.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089866


Locations
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United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Michael Froelich, MD Anesthesiology ad Perioperative Medicine
More Information
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Publications:
Folstein, Marshal F., Susan E. Folstein, and Paul R. McHugh.
Wickelgren, Wayne A.
Deary, Ian J., and Geoff Der.

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Responsible Party: Michael Froelich, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03089866    
Other Study ID Numbers: F141022006
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Froelich, University of Alabama at Birmingham:
Central nervous System
Memory functions
Executive functions
Cognitive impairment
Additional relevant MeSH terms:
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Postoperative Cognitive Complications
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action