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

  • STATUS
    Recruiting
  • End date
    Aug 19, 2021
  • participants needed
    120
  • sponsor
    Pfizer
Updated on 29 November 2020

Summary

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.

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

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Eligibility

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 -
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