NCT04464265

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Apr 2021

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

July 6, 2020

Results QC Date

August 3, 2023

Last Update Submit

August 29, 2023

Conditions

Healthy

Keywords

MusicPropofol

Outcome Measures

Primary Outcomes (1)

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

    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).

    60 minutes

Secondary Outcomes (1)

  • Average Squeeze Pressure Over 60 Minutes

    60 minutes

Study Arms (1)

Functional Magnetic Resonance Imaging

EXPERIMENTAL

While music is played Noninvasive functional magnetic resonance (fMRI) imaging will be performed at the University of Michigan Health System, University Hospital, Department of Radiology. The fMRI is done under anesthesia using propofol. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations of 1.2, 1.6, 2.0, and 2.4 μg/ml in a stepwise fashion.

Other: Functional Magnetic Resonance Imaging (fMRI)

Interventions

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".

Also known as: Diprivan
Functional Magnetic Resonance Imaging

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Zirui Huang, PhD
Organization
University of Michigan Medical School
huangzu@med.umich.edu
734-615-2875

Study Officials

  • Anthony Hudetz, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

April 19, 2021

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)