Neuroimaging Study of Dexmedetomidine-Induced Analgesia

NCT04656470 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019P000996
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• CSF Flow Measured in Hz

  Transient waves of CSF inflow

  During imaging scan

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study was concluded early due to challenges with recruitment

Results Point of Contact

• Title: Johnson Akeju
• Organization: MGH

oluwaseun.akeju@mgh.harvard.edu

6177263030

Study Officials

• Oluwaseun Johnson-Akeju, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Model Details: Patients will receive dexmedetomidine anesthesia during the study visit.

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: December 7, 2020
• Study Start: March 4, 2022
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)