Last updated: March 18, 2022
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
2/3
Condition
Pain
Anesthesia
Treatment
N/AClinical Study ID
NCT04656470
2019P000996
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Cardiovascular: myocardial infarction, coronary artery disease, peripheral vasculardisease, arrhythmia, congestive heart failure, valvular disease, hypertension
- Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness ofbreath
- Hepatic: hepatitis, jaundice, ascites
- Neurologic: seizure, stroke, positive neurologic findings on neurologic examination,multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheralstenosis
- 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 orfamily 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 toaffect CNS function, St. John's Wort
- Allergies: dexmedetomidine, ondansetron, glycopyrrolate, phenylephrine
- Dermatologic: ulcerative skin conditions or other dermatologic conditions which couldinterfere with blood pressure cuff placement.
- MRI reasons for exclusion: History of head trauma, surgical aneurysm clips, cardiacpacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlearimplants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures,metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
Study Design
Total Participants: 20
Study Start date:
March 04, 2022
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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