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Recruiting NCT07290205

Remimazolam NeuroImaging

Early Phase I Interventional Anesthesia Pain Remimazolam

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remimazolam, Peripheral Nerve Stimulation.
Who it may be relevant to
Registry conditions: Anesthesia, Pain, Remimazolam. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neuroimaging of Sedation With Remimazolam

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • Functional connectivity [Time frame: Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT07290205 · STUDY25110017 · R35GM146822

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗