Standardization of Management during Pediatric Sedation for MRI : A Prospective Observational Study

Standardization of Management during Pediatric Sedation for MRI : A Prospective Observational Study - Standardization of Management during Pediatric Sedation for MRI

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011480

Enrollment

Registered

2013-08-14

Start date

2013-08-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants and children who need sedation for MRI

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who require sedation for MRI judged by their doctors. Informed written consent from the legal representatives for the participation of the study.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakuto Takahashi

Tokyo Metropolitan Childrens' Medical Center General Medicine

takuto_takahashi@tmhp.jp042-300-5111

Outcome results