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| ID | Type | Description | Link |
|---|---|---|---|
| R01GM103894 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Squeeze Pressure Over 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Hudetz, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Magnetic Resonance Imaging | 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. Functional Magnetic Resonance Imaging (fMRI): 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". |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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While 47 participants were consented, 15 dropped out prior to receiving the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Magnetic Resonance Imaging | 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. Functional Magnetic Resonance Imaging (fMRI): 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". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Reason of excluding 3 subjects: there were large head motions during fMRI so that the results were not analyzed or pooled in the whole study group. Two additional subjects were excluded, as they withdrew due to physician discretion. | Posted | Mean | Standard Deviation | arbitrary units | 60 minutes |
|
24 hours after drug adminstration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Magnetic Resonance Imaging | 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. Functional Magnetic Resonance Imaging (fMRI): 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". |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Near syncope | Surgical and medical procedures | Systematic Assessment | Participant experienced near syncope during IV insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zirui Huang, PhD | University of Michigan Medical School | 734-615-2875 | huangzu@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2021 | Aug 3, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2022 | Aug 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
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| 60 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
|
|
| Secondary | Average Squeeze Pressure Over 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). | Two subjects were excluded, as they withdrew due to physician discretion. | Posted | Mean | Standard Deviation | mmHg | 60 minutes |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
|
| Paresthesia | Surgical and medical procedures | Systematic Assessment | Participant experienced paresthesia near IV insertion site |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |