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MRI SedationPhase 4NCT04237792

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

A Phase 4 study testing dexmedetomidine and propofol in people with MRI Sedation, run by Pfizer at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month to 16 years
Conditions the study is for
MRI Sedation
What is being tested?
dexmedetomidine and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
23 sitesin 2 countries
Study dates
18 Feb 2020to 30 Nov 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 -

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States16 sites

  • University of Michigan, C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109-4245

  • Children's Healthcare of Atlanta-Egleston

    Atlanta, Georgia, 30322

  • University Hospitals Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

  • Children's Medical Center

    Dallas, Texas, 75235

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Texas Children's Hospital

    Houston, Texas, 77030

  • IU Health Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Baptist Health - Wolfson Children's Hospital

    Jacksonville, Florida, 32207

  • Arkansas Children's

    Little Rock, Arkansas, 72202

  • M Health Fairview University of Minnesota Medical Center - West Bank

    Minneapolis, Minnesota, 55454

  • The Children's Hospital at OUMC

    Oklahoma City, Oklahoma, 73104

  • Lucile Packard Children's Hospital, Stanford

    Palo Alto, California, 94304

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • St. Mary's Medical Center

    West Palm Beach, Florida, 33407

Other trials in United States

Japan7 sites

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, Tokyo, 183-8561

  • Osaka Women's and Children's Hospital

    Izumi-shi, Osaka, 594-1101

  • Ibaraki Children Hospital

    Mito, Ibaraki, 311-4145

  • Osaka City General Hospital

    Osaka, 534-0021

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo, 157-8535

  • Shizuoka Children's Hospital

    Shizuoka, Shizuoka, 420 8660

  • Shikoku Medical Center for Children and Adults

    Zentsujichó, Kagawa-ken, 765-8507

Other trials in Japan

About this study

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

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.

Conditions
MRI Sedation
Keywords
procedural sedation, dexmedetomidine, propofol, MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidineDrug

    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

  • propofolDrug

    propofol IV administration will be given if needed to maintain sedation

Study groups in NCT04237792
Study groupRoleWhat they receive
dexmedetomidine low dose groupExperimentallow dose of dexmedetomidine to be given
Receives: Drug: dexmedetomidine; Drug: propofol
dexmedetomidine middle dose groupExperimentalmiddle dose of dexmedetomidine to be given
Receives: Drug: dexmedetomidine; Drug: propofol
dexmedetomidine high dose groupExperimentalhigh dose of dexmedetomidine to be given
Receives: Drug: dexmedetomidine; Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

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

Secondary outcomes (8)

  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

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

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

  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

    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.

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

  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

    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.

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

  4. 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.

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

  5. 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.

    Measured: Post MRI scan on Day 1 up to 24 hours

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start18 Feb 2020
  3. Primary completion2 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237792
Sponsor's protocol ID
C0801039
Status last verified
Oct 2022
First submitted
17 Jan 2020
Last updated
16 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dexmedetomidine and propofol in people with MRI Sedation, run by Pfizer at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237792.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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