Remimazolam NeuroImaging (REMAZ)

Keith M Vogt

Status and phase: Enrolling; Early Phase 1

Conditions: Remimazolam; Pain; Anesthesia

Treatments: Device: Peripheral Nerve Stimulation; Drug: Remimazolam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07290205

R35GM146822 (Other Grant/Funding Number)

STUDY25110017

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Remimazolam+Pain

Experimental group

Description:

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

Treatment:

Drug: Remimazolam

Device: Peripheral Nerve Stimulation