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Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Primary Purpose

Analgesia, Anesthesia

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional basic science trial for Analgesia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexmedetomidine

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04656470

First Posted

October 1, 2020

Last Updated

March 18, 2022

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04656470

Brief Title

Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Official Title

Neuroimaging Study of Dexmedetomidine-Induced Analgesia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 4, 2022 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia, Anesthesia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Patients will receive dexmedetomidine anesthesia during the study visit.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.

Primary Outcome Measure Information:

Title

Effect of Dexmedetomidine on Pain Processing Circuitry

Description

Time Frame

Change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fMRI visit, an average of 90 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oluwaseun Johnson-Akeju, MD, MMSc

Phone

6177427200

oluwaseun.akeju@mgh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Isabella Turco, BS

Phone

6176432896

iturco@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oluwaseun Johnson-Akeju, MD, MMSc

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.

Phone

617-724-7200

ojohnsonakeju@partners.org

First Name & Middle Initial & Last Name & Degree

Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neuroimaging Study of Dexmedetomidine-Induced Analgesia

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