Ketamine and Propofol NeuroImaging

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Propofol
  Subjects will receive an intravenous infusion of this drug, during portions of the study.
• Препарат Ketamine
  Subjects will receive an intravenous infusion of this drug, during portions of the study.
• Устройство Peripheral Nerve Stimulation
  Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with specific experimental events.

Первичные конечные точки

• Explicit Memory Performance, comparing single-drug to drug-combination condition [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (4)

• MRI-based activation during memory formation, comparing the single-drug condition to the combination-drug condition [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07294092 · STUDY25110029 · R35GM146822

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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