Dexmedetomidine Induced SedationNCT01485380
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep
A study testing dexmedetomidine in people with Dexmedetomidine Induced Sedation, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine Induced Sedation
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I
- 18 to 35 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Dexmedetomidine Induced Sedation
- Being tested
- dexmedetomidine
- Keywords
- Dexmedetomidine, Sleep, MRI-PET, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called precedex
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.
| Study group | Role | What they receive |
|---|---|---|
| Active study arm | Experimental | 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. Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dexmedetomidine Induced SedationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
- Investigators
- Oluwaseun Johnson-Akeju, M.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485380
- Sponsor's protocol ID
- 2011-P-002333
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2011
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep
- ClinicalTrials.gov ID
- NCT01485380
- Acronym / sponsor ID
- 2011-P-002333
- Conditions
- Dexmedetomidine Induced Sedation
- Keywords
- Dexmedetomidine, Sleep, MRI-PET, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 10 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active study arm | Experimental | Drug: dexmedetomidineSubjects 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I
- 18 to 35 years of age
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: precedexThe 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. | Drug | Active study arm |
Primary outcome
Number of Participants With Changes in the Brains Default Mode Network.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dexmedetomidine Induced Sedation
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RecruitingPhase 2
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 4
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
Sedation, Emergence Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluwaseun Johnson-Akeju, M.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine in people with Dexmedetomidine Induced Sedation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Changes in the Brains Default Mode Network. (time frame: 1.5hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.