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The utilization of remimazolam for sedation during pediatric MRI

The utilization of remimazolam for sedation during pediatric MRI

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087949
Enrollment
Unknown
Registered
2024-08-07
Start date
2024-08-07
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Pediatric outpatient sedation

Interventions

Remimazolam group:Remimazolam was injected at 0.3mg/kg
Propofol Group:Propofol was injected at 3mg/kg

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: (1) Informed consent for sedation must be signed by the legal guardians (2) If intranasal dexmedetomidine sedation fails to meet the required depth after 30 minutes of medication or if the child wakes up during the examination, resulting in examination failure. (3) American Society of Anesthesiologists (ASA) grade ?-? is required. (4) Children aged between 3 and 10 years old are eligible. (5) No recent history of sedative use is allowed. (6) There should be no history of allergy to anesthetic drugs. (7) The fasting and water deprivation time must meet the requirements. (8) Body mass index (BMI) should be less than 25.

Exclusion criteria

Exclusion criteria: 1) The family members of the children declined to provide informed consent for their participation in the trial. 2) Subjects with metal implants present in their bodies are excluded from the study. 3) Individuals with a documented history of allergic reactions to anesthetic drugs, active ingredients, and excipients are ineligible for inclusion. 4) Patients with severe congenital heart disease or abnormal liver and kidney function are not eligible for enrollment. 5) Children diagnosed with gastroesophageal reflux will be excluded from the study population. 6) The presence of conscious disturbance symptoms will result in exclusion from participation. 7) Individuals with a medical history of nervous system disorders and mental illness will be excluded.

Design outcomes

Primary

MeasureTime frame
Heart rate ;SpO2;

Secondary

MeasureTime frame
Blood Pressure;

Countries

china

Contacts

Public ContactChengJing Le

Maternal and Child Health Hospital of Hubei Province

8595935@qq.com+86 186 2709 9988

Outcome results

None listed

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