NCT02768688

Brief Summary

This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

April 5, 2016

Last Update Submit

January 23, 2018

Conditions

Glymphatic Flow

Keywords

Human BrainMagnetic Resonance Imaging (MRI)DexmedetomidineCerebral blood flow

Outcome Measures

Primary Outcomes (1)

  • Glymphatic clearance from the human brain

    Assessment of the effect of dexmedetomidine anesthesia on glymphatic flow in subjects as visualized by diffusion tensor MRI.

    2 hours

Study Arms (1)

Brain connectivity and physiology

EXPERIMENTAL

Dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.

Other: Brain connectivity and physiologyDrug: Dexmedetomidine

Interventions

Brain connectivity and physiologyOTHER

MRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness.

Brain connectivity and physiology
DexmedetomidineDRUG

Administering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness.

Brain connectivity and physiology

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Person aged 20-40 years old,
  • American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
  • Body mass index ≤ 30 kg/m2,
  • Easily visualized uvula,
  • Not a current tobacco user
  • No history of alcohol abuse/must abstain from alcohol use 24 hours prior to and 24 hours after participation.
  • Ability to sign informed consent.
  • Able to pass standard MRI safety screening
  • Must have a responsible adult available to transport subject home safely after end of experiment.

You may not qualify if:

  • Healthy male or females less than 20 years of age or older than 40 years of age
  • Any physical signs suggestive of difficult airway (mouth opening 3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
  • History of obstructive sleep apnea,
  • History of asthma
  • Neuropsychiatric disorders,
  • History of, or current use of psychotropic medications,
  • Current tobacco use or history of smoking in past month
  • Alcohol use exceeding 2 drinks/day
  • History of hypertension or current medication for blood pressure control,
  • Cardiovascular disease or arrhythmias,
  • Positive urine toxicology screen,
  • History of gastroesophageal reflux disease,
  • Pregnancy,
  • Sleep disorders,
  • History of postoperative nausea/vomiting or motion sickness,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Functional StatusDexmedetomidine

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Max B Kelz, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

May 11, 2016

Study Start

July 1, 2014

Primary Completion

February 9, 2017

Study Completion

December 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)