University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT02768727
The dual objectives of this study are to determine if the phenomenon of neural inertia is present in humans and to determine whether the order of neurocognitive function is invariant among anesthetic agents. This study will enroll 24 healthy volunteers, ages 20-40 years, who will receive xenon gas (concentrations ranging from 0% to 60%) delivered via inhaled route through the ENHANCER 3000.
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Notify Me20 year–40 year
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
This is a multimodal, nonrandomized study of healthy subjects. After meeting enrollment criteria, subjects will receive a baseline neurocognitive testing on a computer for 15 minutes and will then receive a wrist watch actigraphy device to record their rest/activity patterns over 8-14 days. On the study day (roughly two weeks later), repeat baseline neurocognitive testing will be performed after subjects are fitted with a high density EEG head cap. The actual intervention (delivery of inhaled xenon gas in stepwise increasing followed by decreasing doses) should occur over 2 hours along with verbal tests to assess the presence/absence of consciousness at each xenon concentration. Xenon doses have been chosen specifically to evaluate the point at which individuals lose and then regain consciousness. Doses are escalated up through those used in human anesthesiology (75%) that permit surgery. After exposure, serial neurocognitive testing will occur every 30 minutes for 3 hours post emergence. Subjects are discharged from the study's intervention day to home only upon reaching standard post-anesthesia care unit criteria (modified Aldrete score ≥9). A post-procedure follow up phone call will occur within 24 hours of anesthetic exposure to ensure that the subject remains well. The individual's involvement is completed upon returning the Actigraphy watch 1 week after the exposure day. The expected duration of subject participation is 3 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
drug given in concentrations of 0% to 60% over period of 2 hours
Time frame: 4 hours
To determine in healthy human volunteers if the brain concentrations of xenon (as determined by CT imaging) are identical at the point of loss and return of consciousness.
Time frame: 4 hours
To determine if the order of neurocognitive recovery upon emergence from xenon general anesthesia is sequential or simultaneous and if the former is true to determine if the pattern is identical to that of isoflurane (as measured in a previously completed study).
Time frame: 3 weeks
To determine if xenon induces transient phase shifts in rest-activity rhythms (as measured from actigraphy) as has been previously reported for isoflurane.
Time frame: 4 hours
To determine effects of xenon on brain electrical activity corresponding to loss and subsequent return of consciousness and also at points corresponding to return as each neurocognitive domain returns to its baseline following exposure to xenon as measured by electroencephalogram (EEG).
University of Pennsylvania
Other
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