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This study's purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.
Administering anesthetic drugs to suppress consciousness is an imperatively important step in major surgical operations. Yet the neurobiological mechanisms that underlie loss of consciousness under general anesthesia remain elusive. Despite advancements in understanding the molecular, synaptic, and cellular effects of anesthetics, the large-scale, systems-level modulation of neuronal processes that support conscious cognitive functions is incompletely understood. While profound decreases in global and regional brain metabolism, blood flow, and functional connectivity have been reported, these changes often fail to correlate with the loss and return of consciousness. To date, there is no "consciousness meter" or "gold standard" to objectively assess and monitor the level of consciousness under general anesthesia. Several studies suggest that residual cognitive functions may not completely vanish under general anesthesia; however, the level and complexity of residual information processing in the anesthetized brain remains unknown. Finally, the neurobiological mechanisms that govern anesthesia induction and emergence appear to be partially different, but the relevance of these differences to the modulation of the state of consciousness is unclear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol Administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation | Change = BOLD Response During Sedation - BOLD Response During Baseline | Baseline to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Squeeze Pressure | Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline. | Baseline to 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony G Hudetz, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine - University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol Administration | Propofol: Propofol administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
29 participants were consented and received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Administration | Propofol: Propofol administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation | Change = BOLD Response During Sedation - BOLD Response During Baseline | Intent to study brain activity change (BOLD response) during propofol administration | Posted | Mean | Standard Deviation | percentage of BOLD signal change | Baseline to 90 minutes |
|
|
24 hours
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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 | Propofol Administration | Propofol: Propofol administration | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy McKinney | University of Michigan | 734-647-8129 | adrongo@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 | Mar 10, 2020 | Jun 25, 2020 | Prot_SAP_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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BOLD response | The BOLD (blood oxygen level-dependent) signal is the measured variable as obtained by functional magnetic resonance imaging (fMRI). It is an indirect, relative measure of local neuronal activity in the brain. Higher BOLD signal value indicates more neuronal activity. | Analyzable data was not available for four subjects | Mean | Standard Deviation | percentage of BOLD signal change |
|
| Squeeze pressure | Analyzable data was not available for four subjects | Mean | Standard Deviation | mmHg |
|
|
|
| Secondary | Change From Baseline in Squeeze Pressure | Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline. | Intent to study squeeze pressure change during propofol administration | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline to 90 minutes |
|
|
|
|
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |