Phase 1
N=92
Memory & Conditioning Under Anesthesia
Anesthesia · Pain
Bottom Line
View on ClinicalTrials.gov: NCT04062123 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Explicit Memory Performance — 1.16; .51; 1.04; .98 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dexmedetomidine (Drug); Propofol (Drug); Fentanyl (Drug); Peripheral Nerve Stimulation (Device); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keith M Vogt
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Explicit Memory Performance |
1.16; .51; 1.04; .98 | — |
| SECONDARY Brain Activation in the Hippocampus for Successful Memory Formation: Placebo Condition Minus Drug Condition |
3.8; -4.9; -5.0 | — |
| SECONDARY Heart Rate Response |
— | — |
| SECONDARY Skin Response |
— | — |
Summary
The purpose of this study is to determine the effects of pain on long-term memory and conditioned physiologic responses in the presence and absence of distinct intravenous anesthetics. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena The study will occur over 5 visits and involves no long-term follow up.
Eligibility Criteria
Inclusion Criteria
- Adults, age 18-39, who are native English speakers with at least a high school education
- have normal hearing and memory
- be of normal body-weight
- be generally healthy (free from significant chronic disease)
- have none of the specific exclusion criteria
- have a valid email address and valid phone number throughout the study
- anticipate ability to participate in all visits required for the phase of the study in which they are enrolled
Exclusion Criteria
- Pregnancy
- Body mass index > 35 (obese) or < 18 (underweight)
- Use of psychotropic medications, including anti-epileptics, anti-psychotics, anxiolytics, anti-depressants, stimulants, sleep-aids, anti-histamines, or analgesics
- History of adverse reaction to OR abuse of: dexmedetomidine (Precedex), propofol (Diprivan) or the opioids class of medications (fentanyl, morphine, hydromorphone, etc)
- History of clinically significant memory or hearing loss
- History of obstructive sleep apnea
- History of neurologic or psychiatric disease, including benign tremor
- History of significant cardiac disease, including high blood pressure or arrhythmia
- History of significant pulmonary disease
- History of diabetes or neuropathy
- History of chronic pain, or other pain processing disorder
- Have an implanted medical electronic device
- Have indwelling or implanted metal in their body that is not MRI-compatible
- Have claustrophobia
- Have a history of drug abuse
Data sourced from ClinicalTrials.gov (NCT04062123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.