A Test of Neural Inertia in Humans With Xenon
Status: | Recruiting |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 20 - 40 |
Updated: | 12/1/2018 |
Start Date: | April 2016 |
End Date: | August 2019 |
Contact: | Rupa Chowdary, CRC |
Email: | Rupa.Chowdary@uphs.upenn.edu |
Phone: | 215-615-4105 |
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.
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.
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.
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.
Inclusion Criteria:
- Healthy volunteers ages 20-40 years old
- American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. healthy)
- Body Mass Index <30 kg/m2
- Easily visible uvula
Exclusion Criteria:
- Any physical signs that would suggest a difficult airway (e.g. mouth opening <3cm,
short distance between the chin and neck, poor mandibular subluxation, thick neck)
- History of reactive airway disease
- Current or history of neuropsychiatric disorders
- History or current use of psychotropic medications,
- History or current obstructive sleep apnea
- Current or history of cardiovascular disease or arrhythmias,
- Current or history of chronic sleep disorders
- History of postoperative nausea/vomiting
- Family history of problems with anesthesia (including but not limited to malignant
hyperthermia),
- Current or history of Motion sickness
- Current tobacco use
- Current pregnancy or currently breastfeeding
- Positive urine toxicology screen
- History of seizure disorder, head injury, or brain tumor
- Alcohol consumption greater than 12 drinks per week or more than 4 drinks on any
single day
- Inability to provide informed consent
- Inability to achieve mask seal on intervention day
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Max B Kelz, MD
Phone: 215-615-4105
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