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The Efficacy and Safety of Intranasal Dexmedetomidine Combined with Intravenous Remimazolam in Pediatric MRI

The Efficacy and Safety of Intranasal Dexmedetomidine Combined with Intravenous Remimazolam in Pediatric MRI

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102475
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

none

Interventions

DR Group:intranasal dexmedetomidine combined with intravenous remimazolam
DP Group:intranasal dexmedetomidine combined with intravenous propofol

Sponsors

Guangzhou Women and Children’s Medical Center, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: These patients were aged 1 and 6 years, and had an American Society of Anesthesiologists (ASA) physical status of I–III. Furthermore, the planned imaging duration was not exceeding 60 minutes.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: unstable vital signs, severe cardiovascular, hepatic, or renal function impairment, active upper respiratory infection, severe obstructive sleep apnea syndrome (OSA) or other airway obstructive diseases, allergy history to dexmedetomidine or remimazolam, and patients having received any other sedative 48 hours before sedation. After enrollment, children who were successfully sedated with dexmedetomidine alone and did not require remimazolam or propofol were excluded from further analysis.

Design outcomes

Primary

MeasureTime frame
Sedation efficacy rate;

Secondary

MeasureTime frame
vital signs (Oxygen saturation, Heart rate, Blood pressure);

Countries

China

Contacts

Public ContactWanjun Zheng

Guangzhou Women and Children’s Medical Center, Guangzhou Medical University

77729381@qq.com+86 136 4508 0867

Outcome results

None listed

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