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The 95% effective dose and clinical outcomes of intranasal dexmedetomidine combined with esmketamine for sedation in pediatric magnetic resonance imaging examinations

The 95% effective dose and clinical outcomes of intranasal dexmedetomidine combined with esketamine for sedation in pediatric magnetic resonance imaging examinations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080102
Enrollment
Unknown
Registered
2024-01-19
Start date
2023-04-11
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Sedation for pediatric magnetic resonance imaging examinations

Interventions

Esketamine group(modified sequential method):The nasal dose of dexmedetomidine was 1ug/kg, and the nasal dose of esketamine was arranged in a dose gradient of 0.1mg/kg on an equal scale, with an ini
if the sedation was ineffective, the next case's dose was increased by one gradient, and the process was repeated until 7 exchange points were observed. The lower limit of esketamine nasal dose was 0
Dexmetomidine group (modified sequential method):The nasal dose of esketamine was the ED95 dose measured in the first stage(modified sequential method), and the nasal dose of dexmedetomidine was arran
if the sedation was ineffective, the next case's dose was increased by one gradient, and the procedure was repeated until 7 exchange points were observed. The lower limit of dexmedetomidine nasal dose
Esketamine group (biased coin sequential method):The nasal dose of dexmedetomidine was 1ug/kg, and the nasal dose of esketamine was arranged in a dose gra

Sponsors

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

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: (1) aged from 1 month to 3 years old, regardless of sex; (2) children undergoing a single-site MRI examination and requiring sedation; (3) ASA grade ? ~ ?; (4) informed consent signed by family members; (5) no history of severe upper respiratory tract obstruction.

Exclusion criteria

Exclusion criteria: (1) nasal mucosal injury; (2) severe upper respiratory tract infection; (3) allergy to dexmedetomidine, esketamine, or ketamine; history of failure of deep sedation (4) mental or consciousness disorders; autism or autism (5) cardiac arrhythmias, especially those with chronic arrhythmias; (6) severe obesity (weight =50% above standard weight); (7) The patient's family rejected the proposal.

Design outcomes

Primary

MeasureTime frame
95% effective dose of intranasal dexmetomidine combined with esketamine for pediatric MRI sedation;

Secondary

MeasureTime frame
Blood pressure;Heart rate;Pulse oxygen saturation;Respiratory rate;Sedation onset time ;Sedation maintenance time;Length of PACU stay;

Countries

China

Contacts

Public ContactYaoqin Hu

Children's Hospital, Zhejiang University School of Medicine

huyaoqin@zju.edu.cn+86 151 6711 2579

Outcome results

None listed

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