Postoperative Cognitive DysfunctionNCT03089866
Effect of Sedation on Cognitive Performance in the Elderly
An observational study of Postoperative Cognitive Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Midazolam (0.02mg/kg)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants classified by the American Society of Anesthesiologists (ASA) as a Class I or II patient.
Who may be able to join
- Must be a healthy subject
- 55 years and older
- Able to follow study instructions.
Who cannot join
- Obesity (BMI > 35)
- Non-English speaking/reading
- Sleep apnea
- Moderate to severe bronchial asthma
- Cardiovascular problems including hypertension
- History of claustrophobia
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249
About this study
Official title: Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)
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.
Read the 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).
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Midazolam (0.02mg/kg)
- Keywords
- Central nervous System, Memory functions, Executive functions, Cognitive impairment
- Medical subject headings
- Postoperative Cognitive Complications, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Midazolam (0.02mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a single dose of midazolam on cognitive function.
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores before and after sedation
Measured: Baseline to 1hour
Effect of a single dose of Midazolam on Auditory Activation
Change in Brain activation before and after sedation
Measured: Baseline to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startMar 2015
- Primary completion4 Aug 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Froelich, University of Alabama at Birmingham
- Investigators
- Michael Froelich, MD, Principal investigator, Anesthesiology ad Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089866
- Sponsor's protocol ID
- F141022006
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2017
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.
PubMed 16803914Folstein, Marshal F., Susan E. Folstein, and Paul R. McHugh.
Wickelgren, Wayne A.
Deary, Ian J., and Geoff Der.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sedation on Cognitive Performance in the Elderly (Pilot Study)
- ClinicalTrials.gov ID
- NCT03089866
- Acronym / sponsor ID
- F141022006
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Central nervous System, Memory functions, Executive functions, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASA Patients I or II | – | Drug: Midazolam (0.02mg/kg)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). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants classified by the American Society of Anesthesiologists (ASA) as a Class I or II patient.
Key inclusion criteria (3 listed)
- Must be a healthy subject
- 55 years and older
- Able to follow study instructions.
Key exclusion criteria (20 listed)
- Obesity (BMI > 35)
- Non-English speaking/reading
- Sleep apnea
- Moderate to severe bronchial asthma
- Cardiovascular problems including hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | ASA Patients I or II |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 16803914Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.
- BackgroundFolstein, Marshal F., Susan E. Folstein, and Paul R. McHugh.
- BackgroundWickelgren, Wayne A.
- BackgroundDeary, Ian J., and Geoff Der.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Cognitive Dysfunction
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Froelich, MD principal investigator
Anesthesiology ad Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a single dose of midazolam on cognitive function. (time frame: Baseline to 1hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089866, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.