AnesthesiaREDEXNCT06003127
REcovery From DEXmedetomidine-induced Unconsciousness
A study testing Transcranial Magnetic Stimulation-Electroencephalography in people with Anesthesia and Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Healthy, Consciousness, Level Altered
- What is being tested?
- Transcranial Magnetic Stimulation-Electroencephalography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 to 65
- Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2
- Non-smoker
- No history of taking stimulants or substance abuse
- For women: either use of hormonal contraception, or > 45 years old and last menstrual period > 12 months ago in the absence of any contraceptives.
- American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)
- Fluent in English (sufficient to communicate with the study team and understand the consent form)
Who cannot join
- Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder
- Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)
- Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death
- Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea
- Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
- Hepatic: hepatitis, jaundice, ascites
Show all 14Show fewer
- Renal: acute or chronic severe renal insufficiency
- Reproductive: pregnancy, breast-feeding
- Endocrine: diabetes, thyroid disease, adrenal gland disease
- Hematologic: blood dyscrasias, anemia, coagulopathies
- Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
- Medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception
- Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate
- Potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Schreier, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emery N Brown, MD, PhD, 617-324-1879, ebrown@mgh.harvard.edu
David Schreier, MD, PhD, dschreier@mgh.harvard.edu
About this study
This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.
- Conditions
- Anesthesia, Healthy, Consciousness, Level Altered
- Being tested
- Transcranial Magnetic Stimulation-Electroencephalography
- Keywords
- Dexmedetomidine, EEG, Transcranial magnetic stimulation, Cognition
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation-ElectroencephalographyDevice
Also called TMS-EEG
Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.
| Study group | Role | What they receive |
|---|---|---|
| TMS-EEG Arm | Experimental | This arm will undergo TMS-EEG during the study. Receives: Device: Transcranial Magnetic Stimulation-Electroencephalography |
| Non-TMS-EEG Arm | No intervention | This arm will not undergo TMS-EEG during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return of responsiveness
The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of clicking a button in response to auditory stimulation.
Measured: Up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emery Brown, Massachusetts General Hospital
- Investigators
- Emery N Brown, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003127
- Sponsor's protocol ID
- 2023P001821
- Acronym
- REDEX
- Status last verified
- Jan 2026
- First submitted
- 10 Aug 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2.
PubMed 37142466Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021.
PubMed 34084141
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REcovery From DEXmedetomidine-induced Unconsciousness
- ClinicalTrials.gov ID
- NCT06003127
- Acronym / sponsor ID
- REDEX / 2023P001821
- Conditions
- Anesthesia, Healthy, Consciousness, Level Altered
- Keywords
- Dexmedetomidine, EEG, Transcranial magnetic stimulation, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS-EEG Arm | Experimental | Device: Transcranial Magnetic Stimulation-ElectroencephalographyThis arm will undergo TMS-EEG during the study. |
| Non-TMS-EEG Arm | No intervention | –This arm will not undergo TMS-EEG during the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 to 65
- Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2
- Non-smoker
- No history of taking stimulants or substance abuse
- For women: either use of hormonal contraception, or > 45 years old and last menstrual period > 12 months ago in the absence of any contraceptives.
Key exclusion criteria (14 listed)
- Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder
- Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)
- Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death
- Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea
- Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
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 |
|---|---|---|
| Transcranial Magnetic Stimulation-ElectroencephalographyAlso: TMS-EEGTranscranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG. | Device | TMS-EEG Arm |
Primary outcome
Time to return of responsiveness
Time frame: Up to 120 minutes
The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of clicking a button in response to auditory stimulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 37142466Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2.
- Background: PubMed 34084141Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
David Schreier, MD, PhD contact
Emery N Brown, MD, PhD 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 Transcranial Magnetic Stimulation-Electroencephalography in people with Anesthesia and Healthy, 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emery N Brown, MD, PhD (+1 617-324-1879, ebrown@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return of responsiveness (time frame: Up to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003127, which also lists 2 linked publications.
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 22 Jan 2026.