Trial Outcomes & Findings for A Test of Neural Inertia in Humans With Xenon (NCT NCT02768727)
NCT ID: NCT02768727
Last Updated: 2026-08-31
Results Overview
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. If the values are significantly different, then we conclude that there is evidence for hysteresis in circuits regulating arousal.
COMPLETED
PHASE2
29 participants
4 hours
2026-08-31
Participant Flow
Participant milestones
| Measure |
Xenon
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Xenon
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
|---|---|
|
Overall Study
Failure to meet inclusion criteria despite phone screen
|
5
|
|
Overall Study
Dose-finding timecourse
|
1
|
|
Overall Study
Oral secretions leading to supervising study physician termination of study
|
6
|
|
Overall Study
Equipment failure
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject dislodged xenon mask during exposure
|
1
|
Baseline Characteristics
Analyzed number completing study
Baseline characteristics by cohort
| Measure |
Xenon
n=29 Participants
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants
|
|
Age, Continuous
|
24.0 years
n=29 Participants
|
|
Sex: Female, Male
Enrolled · Female
|
12 Participants
n=29 Participants • Analyzed number completing study
|
|
Sex: Female, Male
Enrolled · Male
|
17 Participants
n=29 Participants • Analyzed number completing study
|
|
Sex: Female, Male
Completing study · Female
|
8 Participants
n=13 Participants • Analyzed number completing study
|
|
Sex: Female, Male
Completing study · Male
|
5 Participants
n=13 Participants • Analyzed number completing study
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Other/No Response
|
3 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: All participants who completed a full induction and emergence xenon exposure with full-length concentration steps.
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. If the values are significantly different, then we conclude that there is evidence for hysteresis in circuits regulating arousal.
Outcome measures
| Measure |
Xenon
n=10 Participants
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
Inactivity Post-Xenon Exposure (Average Minutes/Day)
Post-xenon exposure
|
|---|---|---|
|
Xenon Concentrations at Which Consciousness is Lost and Regained
Loss of Consciousness (Xe)
|
0.4523 Thalamic Xenon (mg/mL)
Standard Error 0.01751
|
—
|
|
Xenon Concentrations at Which Consciousness is Lost and Regained
Return of Consciousness (Xe)
|
0.3096 Thalamic Xenon (mg/mL)
Standard Error 0.02320
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: All participants completing full duration xenon exposure.
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 (PMID: 33970101).
Outcome measures
| Measure |
Xenon
n=10 Participants
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
Inactivity Post-Xenon Exposure (Average Minutes/Day)
Post-xenon exposure
|
|---|---|---|
|
Neurocognitive Recovery Upon Emergence From Xenon as Measured by Neurocognitive Battery Testing
Full neurocognitive recovery within 30 minutes (prior to serial testing)
|
10 Participants
|
—
|
|
Neurocognitive Recovery Upon Emergence From Xenon as Measured by Neurocognitive Battery Testing
other
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 week prior to xenon exposure and 1 week post xenon exposurePopulation: Of the original 10 subjects, Actiwatch data was corrupted by subject wearing the watch in the shower (n=2), was not worn by subjects (n=2), or experienced problems with data transfer (n=2) leaving 4 subject with usable actigraphy data. The average amount of inactivity (min/day) from only 4 subjects was considerably underpowered compared to the study's intended design.
To determine if transient exposure to xenon anesthesia induces a change in rest-activity rhythms (as measured from actigraphy) as has been previously reported for isoflurane. The plan was to collect wrist actigraphy for 1 week before the xenon exposure day and for 1 week following the xenon exposure day. Wrist actigraphy data would be fit with a cosinar analysis function (see Fig 5 from our previous work, PMID: 33970101).
Outcome measures
| Measure |
Xenon
n=4 Participants
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
Inactivity Post-Xenon Exposure (Average Minutes/Day)
n=4 Participants
Post-xenon exposure
|
|---|---|---|
|
Effects of Xenon on Gross Rest / Activity as Measured Using Wristwatch Actigraphy
|
596.8 Minutes of inactivity/day
Standard Deviation 184.7
|
667.3 Minutes of inactivity/day
Standard Deviation 138.2
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Those participants completing full duration xenon exposure with sufficient artifact-free, high-density EEG recordings and CT images through the pineal calcification.
EEG delta power was modeled as a function of estimated brain xenon concentration using nonlinear sigmoidal dose-response curves. Two models were evaluated: 1. a single curve fit to combined induction (increasing xenon concentration) and emergence (decreasing xenon concentration) data, and 2. separate curves fit to induction and emergence phases. Model fit was compared using Akaike Information Criterion (AIC) to assess whether a single (model 1) or phase-specific relationship (model 2) best described the data. Smaller Akaike Information Criterion values indicate a more likely model fit. Typically AIC differences greater than 4 are considered significant.
Outcome measures
| Measure |
Xenon
n=9 Participants
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Xenon: drug given in concentrations of 0% to 60% over period of 2 hours
|
Inactivity Post-Xenon Exposure (Average Minutes/Day)
Post-xenon exposure
|
|---|---|---|
|
Effects of Xenon on Brain Electrical Activity as Measured by EEG Delta Power
Akaike Information Criterion EEG delta power best fit for single curve
|
1558.7 AIC value
|
—
|
|
Effects of Xenon on Brain Electrical Activity as Measured by EEG Delta Power
Akaike Information Criterion EEG delta power best fit by separate induction & emergence curves
|
1390.8 AIC value
|
—
|
Adverse Events
Xenon
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place