Anesthesia, Pain, Remimazolam
Conditions
Keywords
Remimazolam, functional MRI, electric nerve stimulation, sedation, functional connectivity, memory, pain
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
Interventions
DRUGRemimazolam
Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.
DEVICEPeripheral Nerve Stimulation
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.
Sponsors
Keith M Vogt
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Explicit memory performance | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| functional magnetic resonance imaging activation of memory encoding task | Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan | 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. |
| 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 | 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. |
| Functional connectivity | Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan | 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. |
Countries
United States
Contacts
CONTACTKeith M Vogt, MD, PhD
PRINCIPAL_INVESTIGATORKeith M Vogt, MD, PhD
University of Pittsburgh
Outcome results
None listed