AnalgesiaPhase 2/3NCT04656470
Neuroimaging Study of Dexmedetomidine-Induced Analgesia
A Phase 2/3 study testing Dexmedetomidine in people with Analgesia and Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Anesthesia
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 27 May 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.
Read the 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.
- Conditions
- Analgesia, Anesthesia
- Being tested
- Dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Flow Measured in Hz
Transient waves of CSF inflow
Measured: During imaging scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start4 Mar 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive dexmedetomidine anesthesia during the study visit.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
- Investigators
- Oluwaseun Johnson-Akeju, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656470
- Sponsor's protocol ID
- 2019P000996
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2020
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study of Dexmedetomidine-Induced Analgesia
- ClinicalTrials.gov ID
- NCT04656470
- Acronym / sponsor ID
- 2019P000996
- Conditions
- Analgesia, Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive dexmedetomidine anesthesia during the study visit.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDuring 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexPatients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects. | Drug | Dexmedetomidine |
Primary outcome
CSF Flow Measured in Hz
Time frame: During imaging scan
Transient waves of CSF inflow
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluwaseun Johnson-Akeju, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Analgesia and Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF Flow Measured in Hz (time frame: During imaging scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.