Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07290205

Remimazolam NeuroImaging

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Remimazolam Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Keith M Vogt, MD, PhD

CONTACT

[email protected]

4126473147

Keith M. Vogt, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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

    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.

  2. 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

    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.

  3. Functional connectivity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith M Vogt, MD, PhD

CONTACT

[email protected]

4126473147

Sponsors and collaborators

Lead sponsor

Keith M Vogt

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Neuroimaging of Sedation With Remimazolam

Acronym: REMAZ

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.