AnesthesiaEarly Phase 1KAPNINCT07294092
Ketamine and Propofol NeuroImaging
A Early Phase 1 study testing Propofol, Ketamine and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt at 1 site in United States.
Trial summary
This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- Propofol, Ketamine and Peripheral Nerve Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 2 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-59 years of age, who:
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- free from any non-MRI compatible implants
Who cannot join
- are pregnant or attempting to conceive
- body mass index (BMI) > 35
- significant memory impairment or hearing loss
- sleep apnea
- chronic pain or frequently taking pain medication
- chronic medical conditions requiring treatment (hypertension, diabetes, high cholesterol)
Show all 17Show fewer
- neurologic disease, including seizures and tremor
- psychiatric diagnoses, including anxiety, depression, panic, or PTSD
- a history of any of these medical conditions: abnormal heartbeats (cardiac conduction abnormality or arrhythmia), liver or kidney disease, or significant lung disease
- severe claustrophobia or intolerance of an MRI
- have metal implants or non-removable metal piercings
- having a history of adverse reaction to ketamine or propofol
- daily alcohol or heavy alcohol use; history of alcohol abuse
- current daily smoker
- regular or recent marijuana use (including prescribed/medical marijuana)
- illicit drug use, i.e., street drugs
- regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Keith M Vogt, MD, PhD, 4126473147, kev18@pitt.edu
About this study
This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.
Read the detailed description
There are four independent drug-administration sessions, visits 1, 3, 5, and 7. In all four of these sessions, both drugs are received, but in two different sequences. Two of these are EEG sessions and two are MRI sessions. Both EEG and MRI will have the same two drug orderings:
- Propofol alone, followed by ketamine and propofol together
- Ketamine alone, followed by propofol and ketamine together Assignment to propofol alone first, versus ketamine alone first will be randomized. But, all subjects will be assigned to receive both drug orderings under both EEG monitoring and MRI acquisition.
A follow-up memory testing visit will occur the day after each MRI/EEG session, on visits 2, 4, 6, and 8. No drugs are given during the next-day testing sessions.
- Conditions
- Anesthesia, Pain
- Keywords
- Propofol, Ketamine, functional MRI, electric nerve stimulation, sedation, functional connectivity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Subjects will receive an intravenous infusion of this drug, during portions of the study.
KetamineDrug
Also called ketalar
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Peripheral Nerve StimulationDevice
Also called electric nerve stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.
| Study group | Role | What they receive |
|---|---|---|
| Propofol, followed by propofol+ketamine (given at first visit) | Experimental | * Propofol, followed by propofol+ketamine at Visit 1
* Ketamine, followed by ketamine+propofol at Visit 3
* Propofol, followed by propofol+ketamine at Visit 5
* Ketamine, followed by ketamine+propofol at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits. Receives: Drug: Propofol; Drug: Ketamine; Device: Peripheral Nerve Stimulation |
| Ketamine, followed by ketamine+propofol (given at first visit) | Experimental | * Ketamine, followed by ketamine+propofol at Visit 1
* Propofol, followed by propofol+ketamine at Visit 3
* Ketamine, followed by ketamine+propofol at Visit 5
* Propofol, followed by propofol+ketamine at Visit 7
EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits. Receives: Drug: Propofol; Drug: Ketamine; Device: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explicit Memory Performance, comparing single-drug to drug-combination condition
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance.
Measured: Visits 2, 4, 6, and 8. Visits spaced at least 1 week apart, are 1 hour in length, and are 12-36 hours after the preceding visit (1, 3, 5, and 7).
Pain intensity and unpleasantness ratings, comparing single-drug to drug-combination condition
Numerical rating scale (0-10) pain score difference, comparing the single-drug condition to the steady-state dose of the drug-combination condition. Higher pain scores indicate more pain; a positive difference between pain scores during the single-drug condition minus the value during the steady-state dose of the combination-drug condition indicates pain reduction (a better outcome).
Measured: Visits 1, 3, 5, and 7: immediately following each experimental condition. These visits are 3 hours in length and spaced at least 1 week apart.
Secondary outcomes (4)
MRI-based activation during memory formation, comparing the single-drug condition to the combination-drug condition
The Z-score is calculated by linear regression of the task timing against the MRI signal time-course (MRI data is in arbitrary units with no maximum or minimum) at each voxel (single data point in brain). Z-score of 0 indicates no task-related changes. Z-scores further from zero indicate a larger difference in brain activity, with positive values indicating decreases under the combination-drug condition, while negative Z-scores indicate increases under the combination-drug condition, compared to the single-drug condition. This outcome is reported as a number, as it is calculated using all the data across subjects combined into one statistical measure for the overall strength of difference in MRI signal change between two groups of data. Dispersion measures cannot be calculated for the summary Z-score.
Measured: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
MRI-based activation during painful stimulation, comparing the single-drug condition to the combination-drug condition
The Z-score is calculated by linear regression of the task timing against the MRI signal time-course (MRI data is in arbitrary units with no maximum or minimum) at each voxel (single data point in brain). Z-score of 0 indicates no task-related changes. Z-scores further from zero indicate a larger difference in brain activity, with positive values indicating decreases under the combination-drug condition, while negative Z-scores indicate increases under the combination-drug condition, compared to the single-drug conditions. This outcome is reported as a number, as it is calculated using all the data across subjects combined into one statistical measure for the overall strength of difference in MRI signal change between two groups of data. Dispersion measures cannot be calculated for the summary Z-score.
Measured: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
MRI-based changes in functional connectivity, comparing the single-drug condition to the combination-drug condition
Functional connectivity (FC) measures the correlation of MRI signal time-series between brain regions. Changes in FC reflect differences in brain state, in this case between single-drug and combination-drug conditions. A T-statistic of 0 indicates no change; more positive scores mean stronger connectivity in the single-drug condition, and more negative scores mean stronger connectivity with the combination-drug condition. This outcome is a number reflecting the overall magnitude of difference between two datasets, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Measured: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
EEG-based changes in functional connectivity, comparing single-drug to combination-drug condition.
Functional connectivity (FC) measures the correlation of MRI signal time-series between brain regions. Changes in FC reflect differences in brain state, in this case between single-drug and combination-drug conditions. A T-statistic of 0 indicates no change; more positive scores mean stronger connectivity in the single-drug condition, and more negative scores mean stronger connectivity with the combination-drug condition. This outcome is a number reflecting the overall magnitude of difference between two datasets, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Measured: EEG visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute EEG scans: at baseline, under one drug, and under both drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Apr 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion2 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Only the ordering of drug assignments is randomized. After completing all visits, all subjects will have underwent all the same interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keith M Vogt
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor-investigator, Keith M Vogt, University of Pittsburgh
- Investigators
- Keith M Vogt, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294092
- Sponsor's protocol ID
- STUDY25110029
- Other IDs
- R35GM146822
- Acronym
- KAPNI
- Status last verified
- May 2026
- First submitted
- 16 Dec 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data to share: * age, height, weight, sex * survey results quantifying pain predispositions (catastrophizing, vigilance \& anxiety), depression, anxiety, stress, and sleep * pain intensity \& unpleasantness ratings * observer assessment of sedation ratings * Behavioral performance data for long-term memory * structural and functional MRI images
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Propofol NeuroImaging
- ClinicalTrials.gov ID
- NCT07294092
- Acronym / sponsor ID
- KAPNI / STUDY25110029
- Conditions
- Anesthesia, Pain
- Keywords
- Propofol, Ketamine, functional MRI, electric nerve stimulation, sedation, functional connectivity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Keith M VogtUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.
Detailed description
There are four independent drug-administration sessions, visits 1, 3, 5, and 7. In all four of these sessions, both drugs are received, but in two different sequences. Two of these are EEG sessions and two are MRI sessions. Both EEG and MRI will have the same two drug orderings:
- Propofol alone, followed by ketamine and propofol together
- Ketamine alone, followed by propofol and ketamine together Assignment to propofol alone first, versus ketamine alone first will be randomized. But, all subjects will be assigned to receive both drug orderings under both EEG monitoring and MRI acquisition.
A follow-up memory testing visit will occur the day after each MRI/EEG session, on visits 2, 4, 6, and 8. No drugs are given during the next-day testing sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Only the ordering of drug assignments is randomized. After completing all visits, all subjects will have underwent all the same interventions.
| Arm | Type | Receives |
|---|---|---|
| Propofol, followed by propofol+ketamine (given at first visit) | Experimental | Drug: Propofol, Drug: Ketamine, Device: Peripheral Nerve Stimulation* Propofol, followed by propofol+ketamine at Visit 1 * Ketamine, followed by ketamine+propofol at Visit 3 * Propofol, followed by propofol+ketamine at Visit 5 * Ketamine, followed by ketamine+propofol at Visit 7 EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits. |
| Ketamine, followed by ketamine+propofol (given at first visit) | Experimental | Drug: Propofol, Drug: Ketamine, Device: Peripheral Nerve Stimulation* Ketamine, followed by ketamine+propofol at Visit 1 * Propofol, followed by propofol+ketamine at Visit 3 * Ketamine, followed by ketamine+propofol at Visit 5 * Propofol, followed by propofol+ketamine at Visit 7 EEG will be done at either visits 1 and 3 or 5 and 7; fMRI will be done at the other two (non-EEG) visits. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18-59 years of age, who:
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- free from any non-MRI compatible implants
Key exclusion criteria (17 listed)
- are pregnant or attempting to conceive
- body mass index (BMI) > 35
- significant memory impairment or hearing loss
- sleep apnea
- chronic pain or frequently taking pain medication
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 |
|---|---|---|
| PropofolAlso: DiprivanSubjects will receive an intravenous infusion of this drug, during portions of the study. | Drug | Ketamine, followed by ketamine+propofol (given at first visit), Propofol, followed by propofol+ketamine (given at first visit) |
| KetamineAlso: ketalarSubjects will receive an intravenous infusion of this drug, during portions of the study. | Drug | Ketamine, followed by ketamine+propofol (given at first visit), Propofol, followed by propofol+ketamine (given at first visit) |
| Peripheral Nerve StimulationAlso: electric nerve stimulationExperimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events. | Device | Ketamine, followed by ketamine+propofol (given at first visit), Propofol, followed by propofol+ketamine (given at first visit) |
Primary outcome
Explicit Memory Performance, comparing single-drug to drug-combination condition
Time frame: Visits 2, 4, 6, and 8. Visits spaced at least 1 week apart, are 1 hour in length, and are 12-36 hours after the preceding visit (1, 3, 5, and 7).
Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance.
Pain intensity and unpleasantness ratings, comparing single-drug to drug-combination condition
Time frame: Visits 1, 3, 5, and 7: immediately following each experimental condition. These visits are 3 hours in length and spaced at least 1 week apart.
Numerical rating scale (0-10) pain score difference, comparing the single-drug condition to the steady-state dose of the drug-combination condition. Higher pain scores indicate more pain; a positive difference between pain scores during the single-drug condition minus the value during the steady-state dose of the combination-drug condition indicates pain reduction (a better outcome).
4 secondary outcomes
MRI-based activation during memory formation, comparing the single-drug condition to the combination-drug condition
Time frame: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
MRI-based activation during painful stimulation, comparing the single-drug condition to the combination-drug condition
Time frame: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
MRI-based changes in functional connectivity, comparing the single-drug condition to the combination-drug condition
Time frame: MRI visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute MRI scans: at baseline, under one drug, and under both drugs.
EEG-based changes in functional connectivity, comparing single-drug to combination-drug condition.
Time frame: EEG visits (1 and 3, or 5 and 7), which are are 3 hours in length and spaced at least 1 week apart. Data collected at 3 timepoints in 8-minute EEG scans: at baseline, under one drug, and under both drugs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data to share: * age, height, weight, sex * survey results quantifying pain predispositions (catastrophizing, vigilance \& anxiety), depression, anxiety, stress, and sleep * pain intensity \& unpleasantness ratings * observer assessment of sedation ratings * Behavioral performance data for long-term memory * structural and functional MRI images
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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.
Keith M Vogt, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propofol, Ketamine and Peripheral Nerve Stimulation in people with Anesthesia and Pain, run by Keith M Vogt 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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 19 May 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith M Vogt, MD, PhD (4126473147, kev18@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit Memory Performance, comparing single-drug to drug-combination condition (time frame: Visits 2, 4, 6, and 8. Visits spaced at least 1 week apart, are 1 hour in length, and are 12-36 hours after the preceding visit (1, 3, 5, and 7).). The study lists 2 primary outcomes in all. 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 19 May 2026.