Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Anesthesia Clinical Trial

Official title:

Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656470
• Other study ID #: 2019P000996
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 4, 2022
• Est. completion date: March 2024

Study information

• Verified date: March 2022
• Source: Massachusetts General Hospital
• Contact: Oluwaseun Johnson-Akeju, MD, MMSc
• Phone: 6177427200
• Email: oluwaseun.akeju[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Anesthesia

Intervention

Drug:
• Dexmedetomidine
Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Dexmedetomidine on Pain Processing Circuitry	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.	Change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fMRI visit, an average of 90 minutes