Effect of Sedation on Cognitive Performance in the Elderly
キーワード
概要
説明
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).
日付
| 最終確認済み: | 12/31/2019 |
| 最初に提出された: | 03/06/2017 |
| 提出された推定登録数: | 03/22/2017 |
| 最初の投稿: | 03/23/2017 |
| 最終更新が送信されました: | 01/13/2020 |
| 最終更新日: | 01/17/2020 |
| 実際の研究開始日: | 02/28/2015 |
| 一次完了予定日: | 11/30/2020 |
| 研究完了予定日: | 11/30/2021 |
状態または病気
介入/治療
Drug: ASA Patients I or II
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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). |
適格基準
| 研究の対象となる年齢 | 55 Years に 55 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
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]
