A Test of Neural Inertia in Humans With Xenon

University of Pennsylvania

Status and phase

Completed

Phase 2

Conditions

Neurocognitive Dysfunction

Treatments

Drug: Xenon

Study type

Interventional

Funder types

Other

Identifiers

NCT02768727

824229

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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