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Completed

NCT Number: NCT04237792

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

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.

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Key information

Conditions

MRI Sedation

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ibaraki Children Hospital, Mito, Ibaraki, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
  • 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.
  • Planned medical procedure during the MRI scan or post-MRI recovery period.
  • Requires endotracheal intubation or laryngeal mask airway (LMA).
  • Known allergy to eggs, egg products, soybeans or soybean products.
  • SpO2 <93 % on room air -

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

propofol IV administration will be given if needed to maintain sedation

Primary outcomes

  1. Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

    Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.

Secondary outcomes

  1. Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

    Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.

  2. Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

    Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.

  3. Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

    In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.

  4. Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

    Participants who did not have PRO administered were censored.

  5. Emergence Time - By Age Cohort and Combined Age

    Time frame: Post MRI scan on Day 1 up to 24 hours

    Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score >=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score >=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.

  6. Number of Participants Who Received PRO - By Age Cohort and Combined Age

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

  7. Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

  8. Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age

    Time frame: Up to maximum of 3 hours during MRI scan on Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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