Remimazolam effects on brain activity, pain response, and memory during MRI
Neuroimaging of Sedation With Remimazolam
This project sees if the sedative remimazolam changes thinking, pain responses, and brain connectivity in healthy adults aged 18–59 during MRI scans.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07290205 on ClinicalTrials.gov |
What this trial studies
In a single-arm early-phase fMRI protocol, adult participants receive remimazolam while undergoing resting-state and task-based MRI scans. Brain activity will be recorded at rest, during mild electric nerve stimulation to produce noxious input, and while participants perform a memory encoding task. Researchers will compare functional connectivity and activation patterns before, during, and after drug administration to characterize cognitive and nociceptive effects. Enrollees are healthy adults 18–59 without major medical, neurological, or psychiatric conditions and with no MRI contraindications.
Who should consider this trial
Good fit: Adults 18–59 in generally good health without significant medical, neurologic, or psychiatric conditions and who can safely undergo MRI are ideal candidates.
Not a fit: People who are pregnant, have chronic medical conditions, chronic pain, significant psychiatric or neurologic disorders, sleep apnea, or non-MRI-compatible implants are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the results could clarify how remimazolam affects thinking and pain processing and help guide safer dosing and use during sedation.
How similar studies have performed: Prior imaging and pharmacology work has described benzodiazepine effects on brain activity, but remimazolam-specific fMRI investigations are limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Keith M Vogt, MD, PhD — University of Pittsburgh
- Study coordinator: Keith M Vogt, MD, PhD
- Email: kev18@pitt.edu
- Phone: 4126473147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.