Phase 4
N=32
Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04464265 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation — 0.04; 0.01 arbitrary units — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Functional Magnetic Resonance Imaging (fMRI) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation |
0.04; 0.01 | <0.001 sig |
| SECONDARY Average Squeeze Pressure Over 60 Minutes |
11.64; 8.92 | <0.001 sig |
Summary
This study is to better understand the systems-level neuronal mechanisms by which general anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress consciousness by disrupting the functioning of large-scale brain networks that support information integration in the brain.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy, non-smoking, no or minimal alcohol use
- Right-handed
- Body mass index (BMI) of less than 30
- English speakers
Exclusion Criteria
- Medical contraindication to Magnetic Resonance Imaging (MRI) scanning
- Unable to undergo MRI scanning because of possible pregnancy
- BMI over 30
- Tattoos in the head or neck region
- Unwilling to abstain from alcohol for 24 hours prior to dosing
Data sourced from ClinicalTrials.gov (NCT04464265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.