Effect of Sedation on Cognitive Performance in the Elderly

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam (0.02mg/kg)

Drug

Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).

Primary outcomes

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
Effect of a single dose of Midazolam on Auditory Activation

Time frame: Baseline to 1 hour

Change in Brain activation before and after sedation

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Mar 24, 2017
Registry last updated: Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed