Clinical trial NCT05435560: Neurochemical Mechanisms of the Awake vs. Anesthetized Brain
Official title: Characterizing the Neuropharmacology of Dexmedetomidine Through Trimodal Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anesthesia
Healthy
Keywords: Dopamine
Anesthesia
Positron Emission Tomography
Magnetic Resonance Imaging
Electroencephalograpy
Sleep
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2022-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain positron emission tomography (PET) imaging signals.
timeFrame: 2 hours
measure: Functional magnetic resonance imaging (fMRI) signals.
timeFrame: 2 hours
measure: Differences in electroencephalography (EEG) measures between arousal and anesthesia.
timeFrame: 2 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 2 hours
measure: Pulse oximetry
timeFrame: 2 hours
measure: Respiratory physiology
timeFrame: 2 hours
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Athinoula A. Martinos Center for Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Athinoula A. Martinos Center for Biomedical Imaging
name: Christin Y Sander, PhD
role: PRINCIPAL_INVESTIGATOR
References: