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Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

Characterizing the Neuropharmacology of Dexmedetomidine Through Trimodal Imaging

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05435560
Enrollment
30
Registered
2022-06-28
Start date
2022-04-12
Completion date
2023-04-30
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Healthy

Keywords

Dopamine, Anesthesia, Positron Emission Tomography, Magnetic Resonance Imaging, Electroencephalograpy, Sleep

Brief summary

The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.

Detailed description

A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a normal saline infusion, as a control. The order of these two scans will be randomized, and the study design is open label (ie subjects and investigators know which session will be the control scan and which one will be the sedative scan). Investigators hope that by comparing the results of the sedative and control scans, the different neuromodulatory states involved in the transition from wakefulness to medically induced vs naturally occurring sleep can be better understood.

Interventions

DRUGDexmedetomidine

During the imaging scan subjects will receive an initial bolus of dexmedetomidine over 10 minutes. After the bolus has been administered, a constant infusion of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes).

DRUGSaline

During the imaging scan subjects will receive an initial bolus of saline over 10 minutes. After the bolus has been administered, a constant infusion of saline will be maintained for the remainder of the scan (about 60 minutes).

Sponsors

Boston University
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults aged 18-45. * No contraindications to MRI or PET scanning.

Exclusion criteria

* Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia); * Pregnancy or breast feeding; * Current or past history of major medical, neurological, or psychiatric condition; * History of major head trauma; * Any cardiovascular disorders, including heart disorders or high blood pressure \[\>155/95\]; * Breathing problems such as severe asthma; * Bleeding disorder, or use of anticoagulants; * Bladder obstruction, urinary problems, or history of impaired elimination; * Known kidney or liver problems; * Intestinal blockage; * Raynaud syndrome * Peripheral nerve injury; * Diabetes; * Glaucoma; * Sleep disorder, such as sleep apnea, insomnia, or narcolepsy * Current use of any drugs that affect sleep * Current or recent use of medications (neurological or psychiatric) affecting brain function * Current or past history of chronic pain (assessed at discretion of PI); * History of allergic reactions * History of chronic obstructive pulmonary diseases * Ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement * Body mass index above 30 * Current smoker * Lack of current health insurance coverage * Employed under the direct supervision of the investigators conducting the research * Hair in dreadlocks, twists, or braids that cannot be removed * Eczema on the scalp or face

Design outcomes

Primary

MeasureTime frameDescription
Brain positron emission tomography (PET) imaging signals.2 hoursChanges in dopamine receptor availability will be quantified from brain PET images.
Functional magnetic resonance imaging (fMRI) signals.2 hoursfMRI measures of hemodynamic responses.
Differences in electroencephalography (EEG) measures between arousal and anesthesia.2 hoursArousal states will be characterized from changes in the EEG power spectrum.

Secondary

MeasureTime frameDescription
Heart rate2 hoursHeart rate variability.
Pulse oximetry2 hoursAmplitude of pulse oximetry signal.
Respiratory physiology2 hoursBreathing rate (breaths per minute).

Countries

United States

Contacts

Primary ContactIrena Bass, BA
ibass@mgh.harvard.edu617-726-9034
Backup ContactChristin Y Sander, PhD
csander@mgh.harvard.edu617-726-9034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026