Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Phase 2

• Conditions: Anesthesia; Analgesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT04656470
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Status Verified: 2022-03
• Study Start: 2022-03-04
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Effect of Dexmedetomidine on Pain Processing Circuitry	Change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fMRI visit, an average of 90 minutes	fMRI data will be used to compare changes in brain connectivity due to pain using functional network and seed-based correlation analyses when a pain cuff (Hokanson Rapid Cuff Inflator) is inflated during baseline and dexmedetomidine analgesia periods.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States