Skip to content

The application of oral a-mi mixture combined with dexmedetomidine nasal drops in pediatric outpatient MRI examination

The application of oral a-mi mixture combined with dexmedetomidine nasal drops in pediatric outpatient MRI examination

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088572
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

None

Interventions

Medium-dose group:Esketamine+Midazolam oral solution mixture is taken orally+2 µg/kg dexmedetomidine nasal drops
Control group:Dextrose taken orally+3 µg/kg dexmedetomidine nasal drops
Low-dose group:Esketamine+Midazolam oral solution mixture is taken orally+1 µg/kg dexmedetomidine nasal drops
High-dose group:Esketamine+Midazolam oral solution mixture is taken orally+3 µg/kg dexmedetomidine nasal drops 3 µg/kg dexmedetomidine nasal drops

Sponsors

Xi'an International Medical Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: aged 1-6 years with ASA class I-II who were scheduled for outpatient MRI under medium-deep sedation

Exclusion criteria

Exclusion criteria: Allergy to the study drug; Suffering from systemic disease with severe organ dysfunction; Those who have a history of intellectual disability or cognitive impairment and are unable to cooperate; Guardian's refusal to participate in the study; Other reasons that, in the opinion of the investigator, preclude continuation of treatment.

Design outcomes

Primary

MeasureTime frame
The success rate of MRI sedation in children;

Secondary

MeasureTime frame
Children's behavior scores at the time of drug administration;Children's modified sedation Ramsay score every 5 minutes after taking the drug;Time from initiation of dosing to entry into the examination room;Maximum depth of sedation score;The child maintained the behavior score when the child was separated from the parents;Wake time and adverse effects;Radiologist satisfaction and parent satisfaction;

Countries

China

Contacts

Public ContactLi Siyuan

Xi'an International Medical Center Hospital

foxlsy@163.com+86 186 8187 5961

Outcome results

None listed

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