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Completed

NCT Number: NCT04464265

Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional magnetic resonance imaging (fMRI)

Other

Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.

Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".

Other names: Diprivan

Primary outcomes

  1. Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation

    Time frame: 60 minutes

    Music evoked activity was quantified by measurements of the fMRI BOLD signal. Neural response to a natural auditory stimulus, music, was assessed during both conscious and anesthetized states. Measurements were taken at baseline (30 minutes) and during anesthesia (60 minutes).

Secondary outcomes

  1. Average Squeeze Pressure Over 60 Minutes

    Time frame: 60 minutes

    Measurement of force of participants' hand squeezing on a rubber ball in response to instructions. This will be measured in millimeters of mercury (mmHg) of air pressure during squeezing the rubber ball. Measurements are provided for the 30-minute means based on measurements taken every 10 seconds for 30 minutes prior to intervention (baseline) and every 10 seconds for 30 minutes during intervention (intervention), using BIOPAC (https://www.biopac.com) MP160 system with AcqKnowledge software (V5.0).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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