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

Pfizer

Status and phase: Completed; Phase 4

Conditions: MRI Sedation

Treatments: Drug: dexmedetomidine; Drug: propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04237792

C0801039

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 -

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 3 patient groups

dexmedetomidine low dose group

Experimental group

Description:

low dose of dexmedetomidine to be given

Treatment:

Drug: dexmedetomidine

Drug: propofol

dexmedetomidine middle dose group

Experimental group

Description:

middle dose of dexmedetomidine to be given

Treatment:

Drug: dexmedetomidine

Drug: propofol

dexmedetomidine high dose group

Experimental group

Description:

high dose of dexmedetomidine to be given

Treatment:

Drug: dexmedetomidine

Drug: propofol