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

MRI Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237792
• Other study ID #: C0801039
• Status: Completed
• Phase: Phase 4
• Start date: February 18, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 30, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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 -

Related Conditions & MeSH terms

• MRI Sedation

Intervention

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
• propofol
propofol IV administration will be given if needed to maintain sedation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.	Up to maximum of 3 hours during MRI scan on Day 1
Secondary	Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI	Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.	Up to maximum of 3 hours during MRI scan on Day 1
Secondary	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	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.	Up to maximum of 3 hours during MRI scan on Day 1
Secondary	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	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.	Up to maximum of 3 hours during MRI scan on Day 1
Secondary	Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age	Participants who did not have PRO administered were censored.	Up to maximum of 3 hours during MRI scan on Day 1
Secondary	Emergence Time - By Age Cohort and Combined Age	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.	Post MRI scan on Day 1 up to 24 hours
Secondary	Number of Participants Who Received PRO - By Age Cohort and Combined Age		Up to maximum of 3 hours during MRI scan on Day 1
Secondary	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
Secondary	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

External Links

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