Remimazolam NeuroImaging

NCT ID: NCT07290205

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-12-02

Brief Summary

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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

Detailed Description

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Conditions

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Anesthesia Pain Remimazolam

Keywords

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Remimazolam functional MRI electric nerve stimulation sedation functional connectivity memory pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Remimazolam+Pain

Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

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

Peripheral Nerve Stimulation

Intervention Type 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.

Interventions

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Remimazolam

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

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults 18-59 years of age, who:

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Keith M Vogt

OTHER

Sponsor Role lead

Responsible Party

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Keith M Vogt

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Keith M Vogt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Keith M Vogt, MD, PhD

Role: CONTACT

Phone: 4126473147

Email: [email protected]

Facility Contacts

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Keith M Vogt, MD, PhD

Role: primary

Other Identifiers

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R35GM146822

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY25110017

Identifier Type: -

Identifier Source: org_study_id