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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 : Completed
First Posted : January 23, 2020
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
MRI Sedation Drug: dexmedetomidine Drug: propofol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : February 18, 2020
Actual Primary Completion Date : November 2, 2021
Actual Study Completion Date : November 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: dexmedetomidine low dose group
low dose of dexmedetomidine to be given
 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
Experimental: dexmedetomidine middle dose group
middle dose of dexmedetomidine to be given
 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
Experimental: dexmedetomidine high dose group
high dose of dexmedetomidine to be given
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. The proportion of subjects at each DEX dose level who receive PRO [ Time Frame: baseline up to 3 hours ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237792


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04237792    
Other Study ID Numbers: C0801039
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
procedural sedation
dexmedetomidine
propofol
MRI
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action