Status:
UNKNOWN
Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
Lead Sponsor:
Brugmann University Hospital
Conditions:
MRI
Pediatric Sedation
Eligibility:
All Genders
6-6 years
Phase:
PHASE3
Brief Summary
A magnetic resonance imaging (MRI) examination usually takes 30 to 45 minutes and requires the patient to remain perfectly still during the entire acquisition process to ensure quality. Children under...
Eligibility Criteria
Inclusion
- Children of both sexes, aged 6 months to 6 years,
- ASA score I to IV,
- Requiring standard magnetic resonance imaging due to clinical condition, regardless of underlying pathology,
- Sedation performed by an anesthesiologist,
- Written informed consent in accordance with the ICH-GCP and local legislation prior to trial entry.
Exclusion
- Contraindications to MRI (cardiac pacemaker, neurostimulator, ferromagnetic implant),
- Sedation carried out by a non-anesthesiologist,
- Emergency MRI,
- Presence of head trauma,
- Presence of nasal congestion or upper respiratory tract infection on the day of sedation,
- Multiple procedures during the same sedation (operating room, evoked potentials, etc.),
- Children with pathologies requiring airway safety,
- Any known allergic or hypersensitivity reaction to dexmedetomidine,
- Any known allergic or hypersensitivity reaction to benzodiazepines,
- Concomitant use of negative chronotropes, as Digoxine,
- Patient known with chronic respiratory failure or myasthenia,
- Patient known with anatomical abnormality of the airway, lung disease or sleep apnea syndrome
- Patient with known cardiac rhythm abnormality or cardio-vascular disease,
- Patient with known hepatic disorder or chronic kidney disease,
- Patient with hypotension or bradycardia on the day of the examination,
- Patient with a BMI \> 97th percentile (which corresponds to overweight, including obesity).
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05192629
Start Date
March 9 2022
End Date
July 31 2023
Last Update
March 24 2022
Active Locations (1)
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1
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium, 1020