Ketamine and Propofol NeuroImaging (KAPNI)

Keith M Vogt

Status and phase: Enrolling; Early Phase 1

Conditions: Pain; Anesthesia

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07294092

R35GM146822 (Other Grant/Funding Number)

STUDY25110029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

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

Experimental group

Description:

* 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.

Treatment:

Drug: Propofol

Drug: Ketamine

Device: Peripheral Nerve Stimulation

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

Experimental group

Description:

* 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.

Treatment:

Drug: Propofol

Drug: Ketamine

Device: Peripheral Nerve Stimulation