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A randomized, non-inferiority clinical trial on the safety and efficacy of midazolam oral solution combined with dexmedetomidine for sedation in children undergoing magnetic resonance imaging examinations

A randomized, non-inferiority clinical trial on the safety and efficacy of midazolam oral solution combined with dexmedetomidine for sedation in children undergoing magnetic resonance imaging examinations

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121358
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

None

Interventions

A Group :Midazolam orally administered + Dexmedetomidine administered by nasal drip
B Group:Oral chloral hydrate + Intranasal dexmedetomidine

Sponsors

Jiaxing Maternity and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children who require sedation for planned MRI examinations; 2. Patients aged 2–6 years who cannot cooperate; 3. ASAI-II grade, non-cyanotic congenital heart disease patients; 4. Sedation administered by an anesthesiologist; 5. Guardians of the patients voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Children known to be allergic to midazolam, dexmedetomidine, chloral hydrate, or other drugs used; 2. Children with intellectual or cognitive impairments who cannot complete the corresponding assessments (brain injury, cerebral softening, cerebral necrosis, intellectual disability, genetic diseases, various syndromes accompanied by developmental disorders); 3. Children who have used sedative-hypnotic drugs in the past 24 hours; 4. Children who are excessively obese, with a body mass index (BMI) = 23.9 kg/m²; 5. Children who cannot take oral medication due to their own medical conditions; 6. Children who refuse to participate in the study; 7. Children with a history of multiple sedations; 8. Children who have slept within the past 2 hours; 9. Children with acute upper respiratory infections showing catarrhal symptoms; 10. Children who have experienced sleep deprivation; 11. Children with a Ramsay score > 3 at the time of assessment; 12. Children whose examination lasts longer than 30 minutes; 13. Children who experience serious adverse reactions during the study and need to withdraw from intervention.

Design outcomes

Primary

MeasureTime frame
The success rate of sedation after completing the examination;

Secondary

MeasureTime frame
onset time;recovery time;Incidence of adverse events (increased/decreased heart rate, respiratory depression/ apnea, choking cough, mental abnormalities, nausea, vomiting, drowsiness, vertigo, skin itching, etc.);

Countries

China

Contacts

Public ContactYao Hanqing

Jiaxing Maternity and Child Health Care Hospital

yhq20113956@163.com+86 573 8396 3131

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026