Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
60 participants
INTERVENTIONAL
2026-03-01
2028-08-02
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Propofol, followed by propofol+ketamine (given at first visit)
* 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.
Propofol
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Ketamine
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.
Ketamine, followed by ketamine+propofol (given at first visit)
* 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.
Propofol
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Ketamine
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.
Interventions
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Propofol
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Ketamine
Subjects will receive an intravenous infusion of this drug, during portions of the study.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* free from any non-MRI compatible implants
* 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)
* 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
18 Years
59 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Keith M Vogt
OTHER
Responsible Party
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Keith M Vogt
Associate Professor
Principal Investigators
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Keith M Vogt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Keith M Vogt, MD, PhD
Role: primary
Other Identifiers
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STUDY25110029
Identifier Type: -
Identifier Source: org_study_id