Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
NCT ID: NCT04237792
Last Updated: 2022-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2020-02-18
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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dexmedetomidine low dose group
low dose of dexmedetomidine to be given
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
propofol
propofol IV administration will be given if needed to maintain sedation
dexmedetomidine middle dose group
middle dose of dexmedetomidine to be given
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
propofol
propofol IV administration will be given if needed to maintain sedation
dexmedetomidine high dose group
high dose of dexmedetomidine to be given
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
propofol
propofol IV administration will be given if needed to maintain sedation
Interventions
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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
propofol
propofol IV administration will be given if needed to maintain sedation
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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 -
1 Month
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arkansas Children's
Little Rock, Arkansas, United States
Lucile Packard Children's Hospital, Stanford
Palo Alto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Baptist Health - Wolfson Children's Hospital
Jacksonville, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
IU Health Riley Hospital for Children
Indianapolis, Indiana, United States
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
M Health Fairview University of Minnesota Medical Center - West Bank
Minneapolis, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
University Hospitals Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
The Children's Hospital at OUMC
Oklahoma City, Oklahoma, United States
Children's Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Ibaraki Children Hospital
Mito, Ibaraki, Japan
Shikoku Medical Center for Children and Adults
Zentsujichó, Kagawa-ken, Japan
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, Japan
Shizuoka Children's Hospital
Shizuoka, Shizuoka, Japan
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Osaka City General Hospital
Osaka, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C0801039
Identifier Type: -
Identifier Source: org_study_id
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