HealthyPhase 4NCT03361605
Neuroimaging of Anesthetic Modulation of Human Consciousness
A Phase 4 study testing Propofol in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 12 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a body mass index (BMI) less than 30.
- Must be right handed
- Must be English speaking
- Must be capable of giving written informed consent.
- Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.
Who cannot join
- History of obstructive sleep apnea;
- History of a difficult airway with a previous anesthetic;
- History of neurological disorders;
- Hypertension or other cardiovascular abnormalities;
- Pulmonary hypertension or other pulmonary abnormalities;
- Gastroesophageal reflux disease (GERD) or heartburn;
Show all 16Show fewer
- History of significant head injury with loss of consciousness;
- Learning disability or other developmental disorder;
- Allergic reactions to eggs;
- Pregnant or nursing mothers;
- Contraindications to neuroimaging methods;
- Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.
- Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.
- History of drug use, or have a positive drug screen.
- Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.
- Any impairment, activity or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol administration
| Study group | Role | What they receive |
|---|---|---|
| Propofol Administration | Experimental | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
Change = BOLD Response During Sedation - BOLD Response During Baseline
Measured: Baseline to 90 minutes
Secondary outcomes (1)
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.
Measured: Baseline to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start12 Apr 2017
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony G Hudetz, University of Michigan
- Investigators
- Anthony G Hudetz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361605
- Sponsor's protocol ID
- HUM00103361
- Status last verified
- Aug 2020
- First submitted
- 3 Nov 2017
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Anesthetic Modulation of Human Consciousness
- ClinicalTrials.gov ID
- NCT03361605
- Acronym / sponsor ID
- HUM00103361
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 5 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol Administration | Experimental | Drug: Propofol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have a body mass index (BMI) less than 30.
- Must be right handed
- Must be English speaking
- Must be capable of giving written informed consent.
- Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.
Key exclusion criteria (16 listed)
- History of obstructive sleep apnea;
- History of a difficult airway with a previous anesthetic;
- History of neurological disorders;
- Hypertension or other cardiovascular abnormalities;
- Pulmonary hypertension or other pulmonary abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol administration | Drug | Propofol Administration |
Primary outcome
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
Time frame: Baseline to 90 minutes
Change = BOLD Response During Sedation - BOLD Response During Baseline
1 secondary outcome
Change From Baseline in Squeeze Pressure
Time frame: Baseline to 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony G Hudetz, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation (time frame: Baseline to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.