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Alpha-2 Adrenergic Agonist
Dexmedetomidine for Pain Relief
Phase 2 & 3
Waitlist Available
Led By Oluwaseun Johnson-Akeju, MD, MMSc
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18 to 45
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fmri visit, an average of 90 minutes
Awards & highlights
Study Summary
This trial will study the effects of a low dose of the drug dexmedetomidine on pain relief. Neuroimaging data will be collected to understand how the drug works.
Who is the study for?
This trial is for healthy adults aged 18-45 with a BMI ≤ 30, non-smokers, fully vaccinated against COVID-19, and have active health insurance. Excluded are those with neurological conditions like seizures or stroke, endocrine disorders such as diabetes, severe kidney issues, psychiatric problems including depression, pregnant or breastfeeding individuals, liver diseases like hepatitis, certain heart conditions including hypertension and arrhythmia.Check my eligibility
What is being tested?
The study investigates the pain-relieving effects of a low dose of dexmedetomidine using neuroimaging techniques to observe how it works in the brain. Participants will be monitored to understand this medication's analgesic properties.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects such as dry mouth, low blood pressure (hypotension), slow heart rate (bradycardia), nausea or vomiting. It can also make people feel sleepy or dizzy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fmri visit, an average of 90 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fmri visit, an average of 90 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of Dexmedetomidine on Pain Processing Circuitry
Side effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Trial Design
1Treatment groups
Experimental Treatment
Group I: DexmedetomidineExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,335 Total Patients Enrolled
Oluwaseun Johnson-Akeju, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lung issues like COPD, bronchitis, or I smoke.I have not had seizures, strokes, MS, Meniere's, Parkinson's, neuropathy, or peripheral stenosis.I am not on medications that affect brain function or taking St. John's Wort.You have a body mass index (BMI) of 30 or less.I don't have metal implants or a history of severe head injury.I have had surgery or injury to my head, neck, or face, arthritis, or a family history of malignant hyperthermia.You have a history of being treated for a mental health issue like depression.I have acid reflux, a hiatal hernia, or an ulcer.You are allergic to dexmedetomidine, ondansetron, glycopyrrolate, or phenylephrine.I do not have skin conditions that would affect where a blood pressure cuff is placed.I have diabetes or thyroid disease.I have severe kidney problems.I do not have hepatitis, jaundice, or ascites.I am between 18 and 45 years old.I have a blood disorder or am on blood thinners.You do not smoke.I have a heart condition such as heart attack, heart disease, high blood pressure, or irregular heartbeat.You have an American Society of Anesthesiologists (ASA) physical status classification of P1.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a similar precedent for using Ketamine?
"There are 217 ongoing studies investigating ketamine. 41 of those are large-scale phase 3 trials. The majority of these studies originate from Pittsburgh, but there are 403 locations running research related to this treatment option."
Answered by AI
Are patients who are over the age of 55 still eligible for this trial?
"The target age group for this study is 18 to 45 year olds. If a patient does not fit that description, there are other options; 90 clinical trials focus on individuals below the age of 18 and 343 cater to patients over 65."
Answered by AI
What is the recruitment rate for this research project?
"That is correct. The information available on clinicaltrials.gov indicates that the trial is currently looking for 20 individuals to participate across a single site. This particular study was initially posted on March 4th, 2022 and has since been updated on March 18th, 2022."
Answered by AI
Why is Ketamine used both therapeutically and recreationally?
"Ketamine is most commonly used as a general anesthetic, though it can also be employed to treat conditions like pain during surgeries or mechanical ventilation."
Answered by AI
I am interested in enrolling as a subject for this research project, what are the next steps?
"The current clinical trial has a maximum capacity of 20 patients that meet the following two requirements: they must experience pain and be between 18-45 years old."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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