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A Comparative Study on Safety and Efficacy: Ultrasonic Nebulized Esketamine versus Dexmedetomidine for Pediatric Preoperative Sedation

A Comparative Study on Safety and Efficacy: Ultrasonic Nebulized Esketamine versus Dexmedetomidine for Pediatric Preoperative Sedation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115032
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Preoperative sedation in children

Interventions

Control:Dexmedetomidine 2.5 µg/kg was given by nasal drip
Dexmedetomidine:Dexmedetomidine 2.5 µg/kg was added to 3 ml of 0.9% sodium chloride solution and inhaled by an ultrasonic nebulizer
Esketamine:Esketamine 1mg/kg was added to 3 ml of 0.9% sodium chloride solution and inhaled by an ultrasonic nebulizer

Sponsors

Qixingguan District People's Hospital of Bijie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-7 years old; 2. Children undergoing elective surgery under general anesthesia; 3. Asa I-II; 4. Informed consent was obtained from the family members of the children. 5. Duration of surgery <=2 hours.

Exclusion criteria

Exclusion criteria: 1. Allergy to the planned medication; 2. Children with congenital heart disease; 3. Children with diabetes mellitus and severe liver and kidney dysfunction; 4. Children with a recent cold or respiratory illness; 5. Termination of the clinical protocol for any reason and withdrawal at the request of the child's family.

Design outcomes

Primary

MeasureTime frame
Success rate of sedation in children;Onset time of sedation;

Secondary

MeasureTime frame
Incidence of delirium during the recovery period;Incidence of PONV;The length of stay in PACU;

Countries

China

Contacts

Public ContactHui Jiang

Qixingguan District People's Hospital of Bijie

66681587@qq.com+86 137 6509 0547

Outcome results

None listed

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