Standardization of Management during Pediatric Sedation for MRI : A Prospective Observational Study
Phase 2
- Conditions
- Infants and children who need sedation for MRI
- Registration Number
- JPRN-UMIN000011480
- Lead Sponsor
- Tokyo Metropolitan Childrens' Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1 Class3 or 4 in ASA-Physical status 2 Class3 or 4 in Mallampaticlassification 3 Patients who have underlying disease with airway abnormality. 4 Patients with acute respiratory infection 5 Patients with known allergy to benzodiazepines or flumazenil 6 Patients on regular benzodiazepines 7 Previous participation of the study. 8 Patients who are assessed inappropriate for the study judged by the doctor in charge.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of successful sedation, which defined the number of successful sedation cases divided by all cases. Criteria of the successful sedation Little of no motion artifacts on the images judged by radiologists. Completion of MRI within the maximum dosage of the sedative protocol.
- Secondary Outcome Measures
Name Time Method The rate of successful sedation during the length of normal MRI examination, which we set 40 minutes. Adverse events during sedation. Dosages of sedatives, time from the administration of sedatives until the completion of the adequate sedation, the time to return to the normal state of awareness. The delay of the start of MRI from the scheduled time. The rate of acceptable images, which defined the number of acceptable sequences divided by the number of all sequences. Possible correlation between successful sedation and patient characteristics