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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS-EEG Arm | Experimental | This arm will undergo TMS-EEG during the study. |
|
| Non-TMS-EEG Arm | No Intervention | This arm will not undergo TMS-EEG during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation-Electroencephalography | Device | Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emery N Brown, MD, PhD | Contact | +1 617-324-1879 | ebrown@mgh.harvard.edu | |
| David Schreier, MD, PhD | Contact | dschreier@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Emery N Brown, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142466 | Background | 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. | |
| 34084141 |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| Kato 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |