AnesthesiaEarly Phase 1REMAZNCT07290205
Remimazolam NeuroImaging
A Early Phase 1 study testing Remimazolam and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
Trial summary
This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, Remimazolam
- What is being tested?
- Remimazolam and Peripheral Nerve Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 2 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-59 years of age, who:
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- free from any non-MRI compatible implants
Who cannot join
- are pregnant or attempting to conceive
- body mass index (BMI) > 35
- significant memory impairment or hearing loss
- sleep apnea
- chronic pain or frequently taking pain medication (including tramadol)
- chronic medical conditions requiring treatment (hypertension, diabetes, high cholesterol)
Show all 18Show fewer
- neurologic disease, including seizures and tremor
- psychiatric diagnoses, including anxiety, depression, panic, or PTSD
- a history of any of these medical conditions: abnormal heartbeats (cardiac conduction abnormality or arrhythmia), liver or kidney disease, or significant lung disease
- severe claustrophobia or MRI intolerance
- have metal implants or non-removable metal piercings
- having a history of adverse reaction to midazolam (Versed), lorazepam (Ativan) or another benzodiazepine class medication
- are allergic to dextran
- daily alcohol or heavy alcohol use; history of alcohol abuse
- current daily smoker
- regular or recent marijuana use (including prescribed/medical marijuana)
- illicit drug use, i.e., street drugs
- regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Keith M Vogt, MD, PhD, 4126473147, kev18@pitt.edu
Keith M. Vogt, MD, PhD
About this study
Official title: Neuroimaging of Sedation With Remimazolam
This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task
- Conditions
- Anesthesia, Pain, Remimazolam
- Being tested
- Remimazolam, Peripheral Nerve Stimulation
- Keywords
- Remimazolam, functional MRI, electric nerve stimulation, sedation, functional connectivity, memory, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.
Peripheral Nerve StimulationDevice
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam+Pain | Experimental | Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions. Receives: Drug: Remimazolam; Device: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explicit memory performance
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.
Measured: Day/Visit 2: 12-36 hours after day 1 session
subjective pain ratings
Numerical ratings of pain intensity and unpleasantness will be obtained after each experimental period involving repeated noxious stimulation. Values will be on a 0-10 scale, with 0 representing none and 10 representing the worst possible rating.
Measured: Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan
Secondary outcomes (3)
functional magnetic resonance imaging activation of memory encoding task
Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of memory-encoding experimental events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.
Measured: Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
functional magnetic resonance imaging activation of the response to noxious stimulation
Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of noxious stimulation events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.
Measured: Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
Functional connectivity
Whole-brain functional connectivity will be determined in each condition (no-drug and remimazolam). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.
Measured: Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start27 Mar 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keith M Vogt
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor-investigator, Keith M Vogt, University of Pittsburgh
- Investigators
- Keith M Vogt, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290205
- Sponsor's protocol ID
- STUDY25110017
- Other IDs
- R35GM146822
- Acronym
- REMAZ
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data to share: * age, height, weight, sex * pain intensity \& unpleasantness, ratings * observer assessment of sedation at the targeted drug dose * Behavioral performance data for long-term memory * structural and functional MRI images
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Sedation With Remimazolam
- ClinicalTrials.gov ID
- NCT07290205
- Acronym / sponsor ID
- REMAZ / STUDY25110017
- Conditions
- Anesthesia, Pain, Remimazolam
- Keywords
- Remimazolam, functional MRI, electric nerve stimulation, sedation, functional connectivity, memory, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Keith M VogtUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 18 Dec 2025 (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.
This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam+Pain | Experimental | Drug: Remimazolam, Device: Peripheral Nerve StimulationSingle-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18-59 years of age, who:
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- free from any non-MRI compatible implants
Key exclusion criteria (18 listed)
- are pregnant or attempting to conceive
- body mass index (BMI) > 35
- significant memory impairment or hearing loss
- sleep apnea
- chronic pain or frequently taking pain medication (including tramadol)
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 |
|---|---|---|
| RemimazolamSubjects in this group will receive an intravenous infusion of this drug, during a portion of the study. | Drug | Remimazolam+Pain |
| Peripheral Nerve StimulationExperimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants. | Device | Remimazolam+Pain |
Primary outcome
Explicit memory performance
Time frame: Day/Visit 2: 12-36 hours after day 1 session
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.
subjective pain ratings
Time frame: Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan
Numerical ratings of pain intensity and unpleasantness will be obtained after each experimental period involving repeated noxious stimulation. Values will be on a 0-10 scale, with 0 representing none and 10 representing the worst possible rating.
3 secondary outcomes
functional magnetic resonance imaging activation of memory encoding task
Time frame: Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
functional magnetic resonance imaging activation of the response to noxious stimulation
Time frame: Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
Functional connectivity
Time frame: Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data to share: * age, height, weight, sex * pain intensity \& unpleasantness, ratings * observer assessment of sedation at the targeted drug dose * Behavioral performance data for long-term memory * structural and functional MRI images
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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.
Keith M Vogt, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Remimazolam and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt 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 4 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith M Vogt, MD, PhD (4126473147, kev18@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit memory performance (time frame: Day/Visit 2: 12-36 hours after day 1 session). 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?
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 2 Apr 2026.