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

Phase 4

Completed

Conditions: MRI Sedation

Interventions: Drug: dexmedetomidine
Drug: propofol

Registration Number: NCT04237792

Lead Sponsor: Pfizer

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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 -

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine low dose group	propofol	low dose of dexmedetomidine to be given
dexmedetomidine low dose group	dexmedetomidine	low dose of dexmedetomidine to be given
dexmedetomidine middle dose group	propofol	middle dose of dexmedetomidine to be given
dexmedetomidine middle dose group	dexmedetomidine	middle dose of dexmedetomidine to be given
dexmedetomidine high dose group	dexmedetomidine	high dose of dexmedetomidine to be given
dexmedetomidine high dose group	propofol	high dose of dexmedetomidine to be given

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age	Up to maximum of 3 hours during MRI scan on Day 1
Number of Participants Who Received PRO - By Age Cohort and Combined Age	Up to maximum of 3 hours during MRI scan on Day 1
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	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.
Emergence Time - By Age Cohort and Combined Age	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.
Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age	Up to maximum of 3 hours during MRI scan on Day 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	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.
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	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.
Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age	Up to maximum of 3 hours during MRI scan on Day 1	Participants who did not have PRO administered were censored.

Trial Locations

Locations (23): National Center for Child Health and Development
🇯🇵
Setagaya-ku, Tokyo, Japan
Children's Healthcare of Atlanta-Egleston
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Atlanta, Georgia, United States
University Hospitals Rainbow Babies and Children's Hospital
🇺🇸
Cleveland, Ohio, United States
Children's Medical Center
🇺🇸
Dallas, Texas, United States
IU Health Riley Hospital for Children
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Indianapolis, Indiana, United States
M Health Fairview University of Minnesota Medical Center - West Bank
🇺🇸
Minneapolis, Minnesota, United States
The Children's Hospital at OUMC
🇺🇸
Oklahoma City, Oklahoma, United States
Arkansas Children's
🇺🇸
Little Rock, Arkansas, United States
University of California Davis Medical Center
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Sacramento, California, United States
Lucile Packard Children's Hospital, Stanford
🇺🇸
Palo Alto, California, United States
St. Mary's Medical Center
🇺🇸
West Palm Beach, Florida, United States
Brody School of Medicine at East Carolina University
🇺🇸
Greenville, North Carolina, United States
Vidant Medical Center
🇺🇸
Greenville, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Shikoku Medical Center for Children and Adults
🇯🇵
Zentsuji, Kagawa, Japan
Ibaraki Children Hospital
🇯🇵
Mito, Ibaraki, Japan
Osaka Women's and Children's Hospital
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Izumi-shi, Osaka, Japan
Shizuoka Children's Hospital
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Shizuoka-shi, Shizuoka, Japan
Osaka City General Hospital
🇯🇵
Osaka, Japan
Tokyo Metropolitan Children's Medical Center
🇯🇵
Fuchu, Tokyo, Japan
Baptist Health - Wolfson Children's Hospital
🇺🇸
Jacksonville, Florida, United States
University of Michigan, C.S. Mott Children's Hospital
🇺🇸
Ann Arbor, Michigan, United States
Texas Children's Hospital
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Houston, Texas, United States