Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects 1 Month to <17 Years Undergoing MRI Scans

  • End date
    Aug 19, 2021
  • participants needed
  • sponsor
Updated on 29 November 2020


This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects 1 month to <17 years of age undergoing MRI scans in the US and Japan.

Treatment Dexmedetomidine, Propofol
Clinical Study IdentifierNCT04237792
Last Modified on29 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 16 yrs?
Gender: Male or Female
Do you have MRI Sedation?
Do you have any of these conditions: Do you have MRI Sedation??
Do you have any of these conditions: Do you have MRI Sedation??
Male or female subject 1 month and <17 years of age
American Society of Anesthesiologists (ASA) Physical Status I, II or III
Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance
Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete

Exclusion Criteria

Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects
Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts
Planned medical procedure during the MRI scan or post-MRI recovery period
Requires endotracheal intubation or laryngeal mask airway (LMA)
Known allergy to eggs, egg products, soybeans or soybean products
SpO2 <93 % on room air -
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet