A Test of Neural Inertia in Humans With Xenon

NCT02768727 | Completed Phase 2

• 1 other identifier: 824229
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Dysfunction

Keywords

neurocognitive function; neural inertia; xenon gas

Outcome Measures

Primary Outcomes (1)

• 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.

  4 hours

Secondary Outcomes (3)

• Neurocognitive recovery upon emergence from xenon as measured by neurocognitive battery testing

  4 hours

• Effects of xenon on gross motor activity as measured by actigraphy

  3 weeks

• Effects of xenon on brain electrical activity as measured by EEG

  4 hours

Study Arms (1)

Xenon

EXPERIMENTAL

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

Drug: Xenon

Interventions

Xenon DRUG

drug given in concentrations of 0% to 60% over period of 2 hours

Xenon

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognition Disorders

Interventions

Xenon

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Maz B Kelz, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: May 11, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)