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The safety and efficacy of midazolam oral solution combined with dexmedetomidine for sedation cardiacultrasound in children: A multicenter, randomized controlled, non-inferior clinical trial

The safety and efficacy of midazolam oral solution combined with dexmedetomidine for sedation cardiacultrasound in children: A multicenter, randomized controlled, non-inferior clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073977
Enrollment
Unknown
Registered
2023-07-26
Start date
2023-08-01
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Sedation of cardiac ultrasound in children

Interventions

Dexmedetomidine combined with chloral hydrate group:Participants meeting inclusion criteria were sedated with dexmedetomidine combined with chloral hydrate
Dexmedetomidine combined with Midazolam group:Oral medication: (Midazolam oral solution 0.125ml. kg-1)+nasal medication: (dexmedetomidine 0.02ml. kg-1)

Sponsors

Children’s Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.6 Years to 4 Years

Inclusion criteria

Inclusion criteria: 1. Children who need sedation for cardiac ultrasonography; 2. Children aged 6 months to 4 years old who are unable to cooperate; 3. ASA I-III, non-cyanotic heart; 4. The guardian of the children will voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Children known to be allergic to Midazolam, dexmedetomidine and chloral hydrate; 2. Children with intellectual or cognitive impairment who are unable to complete the corresponding assessment; (Brain injury, encephalomalacia, brain necrosis, intellectual disability, genetic diseases, various syndromes accompanied by developmental disorders); 3. Have used sedative and hypnotic drugs within the past 24 hours; 4. Excessive obesity refers to a body mass index (BMI) >= 23.9 kg/m^2; 5. Children who are unable to take medication orally due to their own illness; 6. Children who refuse to participate in the study; 7. Children with multiple history of sedation; 8. Excluding children who have slept within 2 hours; 9. Children with acute upper respiratory infections with symptoms of catarrh; 10. Children with sleep deprivation; 11. Drugs with synergistic effects; (see attachment) 12. Children with a Ramsay score greater than 3 during evaluation.

Design outcomes

Primary

MeasureTime frame
Success rate of sedation;

Secondary

MeasureTime frame
Children's acceptance;Onset time of the two groups;Ramsay sedation score every 5 minutes after medication;Recovery times;

Countries

China

Contacts

Public ContactYing Xu

Children’s Hospital of Chongqing Medical University

xl63632143@163.com+86 139 8340 9393

Outcome results

None listed

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