Recruiting NCT06003127
REcovery From DEXmedetomidine-induced Unconsciousness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Magnetic Stimulation-Electroencephalography.
- Who it may be relevant to
- Registry conditions: Anesthesia, Healthy, Consciousness, Level Altered. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Transcranial Magnetic Stimulation-Electroencephalography
Transcranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.
Primary outcome measures
- Time to return of responsiveness [Time frame: Up to 120 minutes]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
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. PMID 37142466
- 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. PMID 34084141
Identifiers
NCT: NCT06003127 · 2023P001821