Effect of Sedation on Cognitive Performance in the Elderly (NCT03089866) | Clinical Trial Compass
CompletedNot Applicable
Effect of Sedation on Cognitive Performance in the Elderly
United States20 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of a single dose of midazolam on cognitive function.
Timeframe: Baseline to 1hour
2
Effect of a single dose of Midazolam on Auditory Activation