Neuroimaging of Sedation With Remimazolam
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Explicit memory performance
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Remimazolam+Pain
Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.
Intervention: Remimazolam (Drug)
Remimazolam+Pain
Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.
Intervention: Peripheral Nerve Stimulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- functional magnetic resonance imaging activation of memory encoding task(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(Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan)
- Functional connectivity(Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan)
Investigators
Keith M Vogt
Associate Professor
University of Pittsburgh