REcovery From DEXmedetomidine-induced Unconsciousness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation-Electroencephalography
DeviceTranscranial magnetic stimulation of the cerebral cortex and measurement of TMS-evoked potentials in the EEG.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: TMS-EEG ArmExperimental treatment 1 intervention
Group B: Non-TMS-EEG ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 120 minutesSponsors and contacts
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Source ClinicalTrials.gov