Analgesia, Anesthesia
Conditions
Brief summary
Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.
Detailed description
In this trial, participants will be given dexmedetomidine using a single-arm study design. fMRI will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after dexmedetomidine is administered.
Interventions
DRUGDexmedetomidine
Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Patients will receive dexmedetomidine anesthesia during the study visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 to 45 * Normal body weight and habitus, BMI ≤ 30 * Non-smoker * American Society of Anesthesiologists (ASA) physical status classification P1 * Active health insurance coverage * Fully vaccinated against COVID-19
Exclusion criteria
* Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension * Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath * Hepatic: hepatitis, jaundice, ascites * Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis * Gastrointestinal: esophageal reflux, hiatal hernia, ulcer * Endocrine: diabetes, thyroid disease * Renal: acute or chronic severe renal insufficiency * Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy * Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia * Psychiatric: history or treatment for an active psychiatric problem, depression * Reproductive: pregnancy, breast-feeding * Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort * Allergies: dexmedetomidine, ondansetron, glycopyrrolate, phenylephrine * Dermatologic: ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement. * MRI reasons for exclusion: History of head trauma, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures, metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF Flow Measured in Hz | During imaging scan | Transient waves of CSF inflow |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROluwaseun Johnson-Akeju, MD, MMSc
Massachusetts General Hospital
Participant flow
Recruitment details
Institutional email announcing ongoing studies
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
None listed