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Combination of dexmedetomidine and midazolam for children undergoing MRI sedation: a prospective,muticenter, randomized, controlled trial

Combination of dexmedetomidine and midazolam for children undergoing MRI sedation: a prospective,muticenter, randomized, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023334
Enrollment
Unknown
Registered
2019-05-22
Start date
2019-05-27
Completion date
Unknown
Last updated
2019-05-27

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

Conditions

none

Interventions

1:intranasal Dexm+Buccal MDZ
2:Buccal MDZ+Dexm

Sponsors

Guangzhou Women and Children's Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1 Outpatients or inpatients, scheduled to receive sedation for MRI examination. 2 ASA physical status I-III. 3 The subjects must be 3 months to 36 months(inclusive of the 36th month) of age. 4 The scanning time of MRI examination is within 1 hour. 5 The subjects legally authorized representative has given written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1 The subject is allergic to or has a contraindication to any of the drugs or masking flavored syrup used in the study. 2 The subject has cardiac conduction system disease (e.g. 2nd degree AV block). 3 The subject has received digoxin or beta-adrenergic antagonist on the day of the study. 4 The subject has Trisomy 21 (exaggerated risk of bradycardia). 5 The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction). 6 Patients with acute nasal or respiratory symptoms on the day of the study (potential interference with intranasal absorption). 7 The subject has received a dose of any other sedative within 48 hours. 8 The subject has BMI>24(risk of respiratory depression).

Design outcomes

Primary

MeasureTime frame
sedation success rate;

Secondary

MeasureTime frame
blood pressure;Heart rate;adverse reaction;

Countries

United States

Contacts

Public ContactBilian Li

Guangzhou Women and Children's Medical Centre

13570226780@126.com+86 13570226780

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026