Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Mass General Brigham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Analgesia; Anesthesia

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04656470

2019P000996

Details and patient eligibility

About

Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Dexmedetomidine

Experimental group

Description:

During the study visit, patients will be delivered dexmedetomidine anesthesia. 0.5mcg/kg of dexmedetomidine solution will be infused over 10 minutes, and then up to 0.5mcg/kg/hr will be maintained for an additional 20-30 minutes.

Treatment:

Drug: Dexmedetomidine