Effect of Sedation on Cognitive Performance in the Elderly
Keywords
Abstract
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).
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 03/06/2017 |
| Estimated Enrollment Submitted: | 03/22/2017 |
| First Posted: | 03/23/2017 |
| Last Update Submitted: | 01/13/2020 |
| Last Update Posted: | 01/17/2020 |
| Actual Study Start Date: | 02/28/2015 |
| Estimated Primary Completion Date: | 11/30/2020 |
| Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Intervention/treatment
Drug: ASA Patients I or II
Phase
Arm Groups
| Arm | 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: ASA Patients I or II Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time). |
Eligibility Criteria
| Ages Eligible for Study | 55 Years To 55 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Effect of a single dose of midazolam on cognitive function. [Baseline to 1hour]
2. Effect of a single dose of Midazolam on Auditory Activation [Baseline to 1 hour]
