Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
NCT04237792
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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
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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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 120 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 19, 2021 | ||||||
Estimated Primary Completion Date | August 19, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Month to 16 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |