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

NCT04237792

Last updated date
Study Location
University of Miami / Jackson Memorial Hospital
Miami, Florida, 33136, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
MRI Sedation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-16 month
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female subject ≥1 month and <17 years of age.

2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.

3. 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.

4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete

Key

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Pregnant female subjects (including those with an indeterminate or positive pregnancy
test); breastfeeding female subjects.


2. 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.


3. Planned medical procedure during the MRI scan or post-MRI recovery period.


4. Requires endotracheal intubation or laryngeal mask airway (LMA).


5. Known allergy to eggs, egg products, soybeans or soybean products.


6. SpO2 <93 % on room air -

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MRI SedationSafety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans NCT04237792
  1. Miami, Florida
  2. San Francisco, California
  3. San Francisco, California
  4. Indianapolis, Indiana
  5. Indianapolis, Indiana
  6. Mito, Ibaraki
  7. Zentsuji, Kagawa
  8. Izumi-shi, Osaka
  9. Shizuoka-shi, Shizuoka
  10. Fuchu, Tokyo
  11. Setagaya-ku, Tokyo
  12. Osaka,
ALL GENDERS
1 Month+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ?1 Month to <17 Years Undergoing MRI Scans
Official Title  ICMJE A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ?1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE MRI Sedation
Intervention  ICMJE
  • Drug: dexmedetomidine
    dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan
  • Drug: propofol
    propofol IV administration will be given if needed to maintain sedation
Study Arms  ICMJE
  • Experimental: dexmedetomidine low dose group
    low dose of dexmedetomidine to be given
    Interventions:
    • Drug: dexmedetomidine
    • Drug: propofol
  • Experimental: dexmedetomidine middle dose group
    middle dose of dexmedetomidine to be given
    Interventions:
    • Drug: dexmedetomidine
    • Drug: propofol
  • Experimental: dexmedetomidine high dose group
    high dose of dexmedetomidine to be given
    Interventions:
    • Drug: dexmedetomidine
    • Drug: propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Male or female subject ?1 month and <17 years of age.
  2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.
  3. 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.
  4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete

Key Exclusion Criteria:

  1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
  2. 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.
  3. Planned medical procedure during the MRI scan or post-MRI recovery period.
  4. Requires endotracheal intubation or laryngeal mask airway (LMA).
  5. Known allergy to eggs, egg products, soybeans or soybean products.
  6. SpO2 <93 % on room air -
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04237792
Other Study ID Numbers  ICMJE C0801039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP