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A Test of Neural Inertia in Humans With Xenon

Primary Purpose

Neurocognitive Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xenon
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neurocognitive Dysfunction focused on measuring neurocognitive function, neural inertia, xenon gas

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Pennsylvania, Perelman School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xenon

Arm Description

Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.

Outcomes

Primary Outcome Measures

xenon concentrations at which consciousness is lost and regained
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.

Secondary Outcome Measures

Neurocognitive recovery upon emergence from xenon as measured by neurocognitive battery testing
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).
Effects of xenon on gross motor activity as measured by actigraphy
To determine if xenon induces transient phase shifts in rest-activity rhythms (as measured from actigraphy) as has been previously reported for isoflurane.
Effects of xenon on brain electrical activity as measured by EEG
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).

Full Information

First Posted
April 15, 2016
Last Updated
July 6, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02768727
Brief Title
A Test of Neural Inertia in Humans With Xenon
Official Title
A Test of Neural Inertia in Humans With Xenon
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Dysfunction
Keywords
neurocognitive function, neural inertia, xenon gas

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon
Arm Type
Experimental
Arm Description
Xenon anesthesia to determine if neural inertia is present in humans as visualized by CT imaging.
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
drug given in concentrations of 0% to 60% over period of 2 hours
Primary Outcome Measure Information:
Title
xenon concentrations at which consciousness is lost and regained
Description
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
Secondary Outcome Measure Information:
Title
Neurocognitive recovery upon emergence from xenon as measured by neurocognitive battery testing
Description
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
4 hours
Title
Effects of xenon on gross motor activity as measured by actigraphy
Description
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
3 weeks
Title
Effects of xenon on brain electrical activity as measured by EEG
Description
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).
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maz B Kelz, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania, Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Test of Neural Inertia in Humans With Xenon

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