Trial Outcomes & Findings for Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep (NCT NCT01485380)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1.5hrs

Results posted on

2019-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Active Study Arm Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography 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.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Study Arm n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Active Study Arm n=17 Participants Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) 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 on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli.
Number of Participants With Changes in the Brains Default Mode Network.	16 participants

Adverse Events

Active Study Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Oluwaseun Johnson-Akeju

Massachusetts General Hospital

Phone: 6177247200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place