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Discussion on the optimal dose of oral midazolam combined with dexmedetomidine for nasal sedation during MRI in children by Modified Dixon's Up - and - Down Method

Discussion on the optimal dose of oral midazolam combined with dexmedetomidine for nasal sedation during MRI in children by Modified Dixon's Up - and - Down Method

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068611
Enrollment
Unknown
Registered
2023-02-24
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Pediatric procedural sedation

Interventions

Intervention group:Dexmedetomidine(modified sequential method) + midazolam
Intervention group:Dexmedetomidine + Midazolam (Modified sequential method)

Sponsors

Children's hospital,School of Medicine,Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: (1) Age 0-6 years old, gender unlimited; (2) children undergoing MRI and requiring sedation; (3)ASA grade I-II; (4) Informed consent signed by the family members of the children; (5) No history of severe upper respiratory tract obstruction.

Exclusion criteria

Exclusion criteria: (1) nasal mucosa injury in children; (2) severe upper respiratory tract infection; (3) History of sedative drug allergy; (4) mental or conscious disorders; (5) arrhythmia, especially chronic arrhythmia; (6) Severe obesity (body weight more than 50% of the standard body weight).

Design outcomes

Primary

MeasureTime frame
Sleep Latency;Recovery time;Sedation success rate;

Secondary

MeasureTime frame
Heart rate;Blood pressure;Oxygen saturation;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactYaoqin Hu

Children's hospital,School of Medicine,Zhejiang University

huyaoqin@zju.edu.cn15167112579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026