Dexmedetomidine Induced Sedation
Conditions
Keywords
Dexmedetomidine, Sleep, MRI-PET, EEG
Brief summary
The investigators are doing this research study to find out how and where dexmedetomidine, a sedative anesthetic, acts in the brain. The investigators will do this by using a machine that records the brains electrical activity, called an electroencephalogram (EEG), and brain imaging scans to look at the brain.
Interventions
DRUGdexmedetomidine
The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I * 18 to 35 years of age
Exclusion criteria
* MRI and/or PET screening criteria not met * Abnormal sleep habits/known or suspected sleep disorder(s) * Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in the Brains Default Mode Network. | 1.5hrs | Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Study Arm Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.
dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Active Study Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With Changes in the Brains Default Mode Network.
Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states.
Time frame: 1.5hrs
Population: All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Study Arm | Number of Participants With Changes in the Brains Default Mode Network. | 16 participants |