Ketamine and Propofol NeuroImaging

NCT07294092 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY25110029R35GM146822
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anesthesia

Keywords

Propofol; Ketamine; functional MRI; electric nerve stimulation; sedation; functional connectivity

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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

  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

  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

  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.

  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.

Study Arms (2)

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.

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.

Drug: Propofol; Drug: Ketamine; Device: Peripheral Nerve Stimulation

Interventions

Ketamine DRUG

Subjects will receive an intravenous infusion of this drug, during portions of the study.

Also known as: ketalar

Ketamine, followed by ketamine+propofol (given at first visit); Propofol, followed by propofol+ketamine (given at first visit)

Propofol DRUG

Subjects will receive an intravenous infusion of this drug, during portions of the study.

Also known as: Diprivan

Ketamine, followed by ketamine+propofol (given at first visit); Propofol, followed by propofol+ketamine (given at first visit)

Peripheral Nerve Stimulation DEVICE

Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.

Also known as: electric nerve stimulation

Ketamine, followed by ketamine+propofol (given at first visit); Propofol, followed by propofol+ketamine (given at first visit)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18-59 years of age, who:

You may not qualify if:

• have a valid email address and valid phone number throughout the study
• 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

Sponsors & Collaborators

• Keith M Vogt: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Propofol; Ketamine; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith M Vogt, MD, PhD

CONTACT

4126473147; kev18@pitt.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed which agent is being administered first, but do know they will receive both in each drug session.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Only the ordering of drug assignments is randomized. After completing all visits, all subjects will have underwent all the same interventions.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 19, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 2, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.
• Access Criteria: Data will be shared via a publicly-accessible online platform that allows user download at no cost.

Locations

US (1)