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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT04237792

Collaborator

(none)

129

Enrollment

Locations

Arms

21.4

Actual Duration (Months)

5.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Feb 18, 2020

Actual Primary Completion Date :

Nov 2, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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

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

Primary Outcome Measures

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 [baseline up to 3 hours]

Secondary Outcome Measures

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 [baseline up to 3 hours]
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 [baseline up to 3 hours]
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 [baseline up to 3 hours]
The amount of time from the start of the DEX loading dose infusion to the time of the first PRO bolus administration [baseline up to 3 hours]
Emergence time (defined as the time from the end of the MRI scan to when the subject meets a Modified Aldrete Score ≥9) [post-procedure up to 24 hours]
The proportion of subjects at each DEX dose level who receive PRO [baseline up to 3 hours]
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 [baseline up to 3 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's	Little Rock	Arkansas	United States	72202
2	Lucile Packard Children's Hospital, Stanford	Palo Alto	California	United States	94304
3	University of California Davis Medical Center	Sacramento	California	United States	95817
4	Baptist Health - Wolfson Children's Hospital	Jacksonville	Florida	United States	32207
5	St. Mary's Medical Center	West Palm Beach	Florida	United States	33407
6	Children's Healthcare of Atlanta-Egleston	Atlanta	Georgia	United States	30322
7	IU Health Riley Hospital for Children	Indianapolis	Indiana	United States	46202
8	University of Michigan, C.S. Mott Children's Hospital	Ann Arbor	Michigan	United States	48109-4245
9	M Health Fairview University of Minnesota Medical Center - West Bank	Minneapolis	Minnesota	United States	55454
10	Duke University Medical Center	Durham	North Carolina	United States	27710
11	Brody School of Medicine at East Carolina University	Greenville	North Carolina	United States	27834
12	Vidant Medical Center	Greenville	North Carolina	United States	27834
13	University Hospitals Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
14	The Children's Hospital at OUMC	Oklahoma City	Oklahoma	United States	73104
15	Children's Medical Center	Dallas	Texas	United States	75235
16	Texas Children's Hospital	Houston	Texas	United States	77030
17	Ibaraki Children Hospital	Mito	Ibaraki	Japan	311-4145
18	Shikoku Medical Center for Children and Adults	Zentsuji	Kagawa	Japan	765-8507
19	Osaka Women's and Children's Hospital	Izumi-shi	Osaka	Japan	594-1101
20	Shizuoka Children's Hospital	Shizuoka-shi	Shizuoka	Japan	420 8660
21	Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo	Japan	183-8561
22	National Center for Child Health and Development	Setagaya-ku	Tokyo	Japan	157-8535
23	Osaka City General Hospital	Osaka		Japan	534-0021