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Comparison of different doses of intranasal dexmedetomidine combined with Esketamine for preoperative sedation in preschool children

Comparison of different doses of intranasal dexmedetomidine combined with Esketamine for preoperative sedation in preschool children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071974
Enrollment
Unknown
Registered
2023-05-30
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Preoperative sedation

Interventions

experimental group DS1:Dexmedetomidine 1ug/kg+ esketamine 0.5mg/kg nasal drops 30min before surgery
experimental group DS2:Dexmedetomidine 1.5ug/kg+ esketamine 0.5mg/kg nasal drops 30min before surgery
experimental group DS3:Dexmedetomidine 2ug/kg+ esketamine 0.5mg/kg nasal drops 30min before surgery

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: (1) Age 2-6 years old, gender unlimited; (2) Tonsil/adenoidectomy under sevoflurane anesthesia was performed at selected time, and the operation time was less than 2 hours; (3) ASA grade ? ~ ?; (4) No history of severe upper respiratory tract obstruction; (5) Informed consent signed by the family members of the children;

Exclusion criteria

Exclusion criteria: (1) Allergic to dexmedetomidine or esketamine; (2) Congenital heart disease (tetralogy of Fallot, patent ductus arteriosus, ventricular septal defect, etc.); (3) lung diseases (lung infection, bronchial asthma, etc.); (4) known rhinitis or nasal deformity; (5) growth retardation; (6) diseases of nervous system; (7) Refusing to take medication before nasal drops;

Design outcomes

Primary

MeasureTime frame
Sedation level after 30 minutes of intervention;

Secondary

MeasureTime frame
Time of onset of sedation;Parental separation anxiety score;Mask acceptance score;Recovery time;

Countries

China

Contacts

Public ContactXinna Wu

The Children's Hospital, School of Medicine, Zhejiang University

13567164071@163.com+86 135 6716 4071

Outcome results

None listed

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