Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Last updated: March 18, 2022
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Pain

Anesthesia

Treatment

N/A

Clinical Study ID

NCT04656470
2019P000996
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

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

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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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