Recruiting
Early Phase 1

Remimazolam

Sponsor:

Keith M Vogt

Code:

NCT07290205

Conditions

Anesthesia

Pain

Remimazolam

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

Remimazolam

Peripheral Nerve Stimulation

Study Details

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

Conditions

Anesthesia

Pain

Remimazolam

Study ID

NCT07290205

Start date

Mar 27, 2026

Status verified date

Mar, 2026

Completion date

Dec 2, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Remimazolam

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

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.

Primary outcome measure

  • Explicit memory performance [ Time Frame: Day/Visit 2: 12-36 hours after day 1 session ]
  • subjective pain ratings [ Time Frame: Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan ]

Central Contacts and Locations

Central contacts

Keith M Vogt, MD, PhD

4126473147kev18@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Keith M Vogt, MD, PhD

4126473147kev18@pitt.edu

Principal Investigator:

Keith M. Vogt, MD, PhD

More Information

Sponsor

Keith M Vogt

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • Remimazolam
  • functional MRI
  • electric nerve stimulation
  • sedation
  • functional connectivity
  • memory
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Keith M Vogt on 2026-04-02.