Understanding recovery from dexmedetomidine-induced unconsciousness
REcovery From DEXmedetomidine-induced Unconsciousness
This study is testing how biological sex affects recovery from unconsciousness caused by a medication called dexmedetomidine in healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06003127 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates how biological sex influences recovery from unconsciousness induced by dexmedetomidine in healthy volunteers. It employs transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) to assess brain complexity during sedation without waking participants. The study aims to provide insights into the effects of dexmedetomidine on consciousness and recovery processes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a normal BMI and no significant medical history.
Not a fit: Patients with neurological or psychiatric disorders, or those with a history of substance abuse, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of recovery from sedation, potentially leading to improved anesthetic practices.
How similar studies have performed: While studies on dexmedetomidine and sedation exist, the specific combination of TMS-EEG in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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).
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Emery N Brown, MD, PhD — Massachusetts General Hospital
- Study coordinator: Emery N Brown, MD, PhD
- Email: ebrown@mgh.harvard.edu
- Phone: +1 617-324-1879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.