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

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ClinicalTrials.gov Identifier: NCT04237792
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 17, 2020
First Posted Date  ICMJE January 23, 2020
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE February 18, 2020
Estimated Primary Completion Date July 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
Percent of subjects at the DEX high dose level versus the low dose level in the combined age cohorts who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 3 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
Percent of subjects at the DEX high dose level versus the low dose level who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 2 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
  • Percent of subjects at the DEX high dose level versus the low dose level in each age cohort who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 3 hours ]
  • Percent of subjects at the DEX middle dose level compared to the high dose level and the low dose level in both the overall sample and in each age cohort who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 3 hours ]
  • Percent of time at the target sedation rating scale score (Pediatric Sedation State Scale [PSSS] rating of 2) after the administration of the DEX loading dose and during the DEX maintenance infusion [ Time Frame: baseline up to 3 hours ]
  • The amount of time from the start of the DEX loading dose infusion to the time of the first PRO bolus administration [ Time Frame: baseline up to 3 hours ]
  • Emergence time (defined as the time from the end of the MRI scan to when the subject meets a Modified Aldrete Score ≥9) [ Time Frame: post-procedure up to 24 hours ]
  • The proportion of subjects at each DEX dose level who receive PRO [ Time Frame: baseline up to 3 hours ]
  • Total amount (mg/kg) and weight and time adjusted amount (per kg per minute basis) of concomitant PRO required to successfully complete the MRI scan [ Time Frame: baseline up to 3 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
  • Percent of subjects at the DEX high dose level versus the low dose level in each age cohort who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 2 hours ]
  • Percent of subjects at the DEX middle dose level compared to the high dose level and the low dose level in both the overall sample and in each age cohort who do not require concomitant PRO to complete the MRI [ Time Frame: baseline up to 2 hours ]
  • Percent of time at the target sedation rating scale score (Pediatric Sedation State Scale [PSSS] rating of 2) after the administration of the DEX loading dose and during the DEX maintenance infusion [ Time Frame: baseline up to 2 hours ]
  • The amount of time from the start of the DEX loading dose infusion to the time of the first PRO bolus administration [ Time Frame: baseline up to 2 hours ]
  • Emergence time (defined as the time from the end of the MRI scan to when the subject meets a Modified Aldrete Score ≥9) [ Time Frame: post-procedure up to 24 hours ]
  • The proportion of subjects at each DEX dose level who receive PRO [ Time Frame: baseline up to 2 hours ]
  • Total amount (mg/kg) and weight and time adjusted amount (per kg per minute basis) of concomitant PRO required to successfully complete the MRI scan [ Time Frame: baseline up to 2 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 July 28, 2021
Estimated Primary Completion Date July 28, 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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2021

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