Remimazolam NeuroImaging (REMAZ)

Neuroimaging of Sedation With Remimazolam

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 Overview

• Status: Recruiting
• Conditions: Pain; Anesthesia; Remimazolam
• Intervention / Treatment: Device: Peripheral Nerve Stimulation; Drug: Remimazolam

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Keith M Vogt, MD, PhD; Phone Number: 4126473147; Email: kev18@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Keith M Vogt, MD, PhD; Phone Number: 4126473147; Email: kev18@pitt.edu
      • Principal Investigator: Keith M. Vogt, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam+Pain; Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.	Device: Peripheral 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.; Drug: Remimazolam; Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day/Visit 2: 12-36 hours after day 1 session
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.	Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan
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.	Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan

Collaborators and Investigators

• Sponsor: Keith M Vogt
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Keith M Vogt, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 2, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: memory; pain; functional MRI; sedation; functional connectivity; Remimazolam; electric nerve stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; remimazolam
• Other Study ID Numbers: STUDY25110017; R35GM146822 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data to share:

• age, height, weight, sex
• pain intensity & unpleasantness, ratings
• observer assessment of sedation at the targeted drug dose
• Behavioral performance data for long-term memory
• structural and functional MRI images

• IPD Sharing Time Frame: After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.
• IPD Sharing Access Criteria: Data will be shared via a publicly-accessible online platform that allows user download at no cost.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No