Neuroimaging Study of Dexmedetomidine-Induced Analgesia

NCT ID: NCT04656470

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-04

Study Completion Date

2025-05-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Analgesia Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will receive dexmedetomidine anesthesia during the study visit.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oluwaseun Johnson-Akeju, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2019P000996

Identifier Type: -

Identifier Source: org_study_id

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