Health TrialsbyHealthPanel

Remimazolam NeuroImaging

ConditionsAnesthesiaPainRemimazolam
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-59
SponsorKeith M Vogt

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

have none of the specific

Disqualifiers

have a valid email address and valid phone number throughout the study

free from any non-MRI compatible implants

are pregnant or attempting to conceive

body mass index (BMI) > 35

Trial design

Design model

Single group

Treatments tested in this trial

  • Remimazolam

    Drug

    Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.

  • Peripheral Nerve Stimulation

    Device

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Remimazolam+PainExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day/Visit 2: 12-36 hours after day 1 session
2

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.

Time frame
Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan

Secondary outcomes

1

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.

Time frame
Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
2

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.

Time frame
Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
3

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.

Time frame
Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keith M Vogt

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov
Apply now