pre-school pediatric population undergoing magnetic resonance imaging
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: dexmedetomidine
CAS Number: 145108-58-3
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Concent
Sponsors
Hôpital Universitaire Des Enfants Reine Fabiola
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children of both genders aged 6 months to 6 years, • ASA score I to IV, • Requiring standard of care MRI due to subject’s clinical status, regardless of the underlying pathology, • Sedation carried out by an anesthesiologist • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Are the trial subjects under 18? yes Number of subjects for this age range: 250 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Emergency MRI • Presence of head trauma • Presence of nasal congestion or upper respiratory tract infection on the day of sedation • Children with pathologies requiring airway safety • Any known allergic or hypersensitivity reaction to dexmedetomidine and benzodiazepine • 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 and known 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in a propofol boluses sedation based on the occurrence of any undesirable events during the MRI procedure requiring temporary or definitive interruption of the examination.;Secondary Objective: •To assess the synergistic effect between dexmedetomidine and propofol •To assess the impact of external factors on the primary outcome •To assess the impact of dexmedetomidine on the post-sedation period •To assess subject acceptability of intranasal premedication by the CHEOPS scale •To assess the quality of MRI images;Primary end point(s): • Incidence and type of any undesirable event during the MRI procedure requiring temporary or definitive interruption of the examination (bradycardia, hypotension, desaturation under 95%, unvoluntary movements of subject);Timepoint(s) of evaluation of this end point: At the end of MRI procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cumulative dose in mg/kg of propofol administered during the procedure • Number and total dose administered in mg of additional bolus of propofol • Time to Aldrete’s score > 9/10 and Chung's score > 9/10 (= time to discharge from the hospital) • Length of stay in the post-anaesthesia care unit • Assessment of the influence of external factors • Assessment of premedication’s acceptability by the CHEOPS scale • Classification of MRI images into 2 groups: “without” and “with artefact”.;Timepoint(s) of evaluation of this end point: • At the end of MRI procedure for cumulative dose in mg/kg of propofol and number of aditional bolus • At the end of subject's hospital stay for Aldrete's score, Chung's score, lenght of stay and premedication’s acceptability • Up to 24H post MRI procedure for AE/SAE reporting | — |
Countries
Belgium
Contacts
Public ContactClinical Research Unit
Hôpital Universitaire Des Enfants Reine Fabiola
Outcome results
None listed