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Assessment of the Efficacy and Safety of Dexmedetomidine Nasal Spray for Sedation Prior to MRI in Pediatric Patients

The Effectiveness and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Sedation Prior to MRI in Pediatric Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100971
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Sedation before MRI examination

Interventions

Test group:Subjects were sedated using dexmedetomidine nasal spray combined with midazolam oral solution
Control group:Subjects were sedated using dexmedetomidine hydrochloride nasal drops combined with midazolam oral solution

Sponsors

Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 2 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-II level; 2. Age 1-2 years old; 3. Children weighing 10-15kg 4. requiring sedation before MRI examination

Exclusion criteria

Exclusion criteria: 1. ASAIII level and above; 2. nasal mucosa injury in children; 3. severe upper respiratory tract infection; 4. dysfunction of liver and kidney; 5. History of sedative drug allergy; 6. Experienced general anesthesia within 2 weeks; 7.Use of sedative hypnotics (including benzodiazepines such as diazepam and barbiturates such as phenobarbital, etc.) within 1 week; 8. mental system diseases and cognitive dysfunction; 9. Arrhythmia, especially chronic arrhythmia; 10. Severe obesity (weight =50% above the standard body weight); 11. follow-up missing; 12. Refuse to participate in this study; 13. Other conditions that the investigator determines are not suitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
sedation onset time;sedation recovery time;overall sedation time; adverse event;Sedation satisfaction rate;Success rate of rescue sedation;vital signs;

Countries

China

Contacts

Public ContactJinjin Huang

Children's Hospital, Zhejiang University, School of Medicine

6196008@zju.edu.cn+86 136 0652 2815

Outcome results

None listed

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