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Study on the application of dexmedetomidine combined with Esketamine nasal drops before tonsillectomy in children

Study on the application of dexmedetomidine combined with Esketamine nasal drops before tonsillectomy in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107412
Enrollment
Unknown
Registered
2025-08-11
Start date
2024-01-29
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

amygdalitis

Interventions

Sequential test group:The first part: to determine the optimal nasal compatible dose of esmketamine and dexmedetomidine by modified Dixon sequential method
Control group:Intranasal drip of dexmedetomidine 3 µ g/kg
Observation group:Intranasal drip of dexmedetomidine 2 µ G/kg, and 95% of Esketamine ED

Sponsors

Huzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: ASA grade I to II; Tonsillectomy was performed in our hospital; Age 3~7 years old, weight 10~30 kg (BMI 13~24 kg/m^2); ECG showed no abnormality and atropine test was negative; There was no anemia and metabolic disorder (including water, electrolyte, acid-base balance disorder) before operation;

Exclusion criteria

Exclusion criteria: History of systemic diseases (congenital heart disease, asthma or central nervous system disease, etc.), abnormal liver and kidney function, drug or food allergy history, abnormal nasal structure; Have a history of upper respiratory tract infection in the past two weeks and have used Dex, etc. one month before operation a 2 Receptor agonists and other drugs that affect the test results.

Design outcomes

Primary

MeasureTime frame
blood pressure;SpO2;heart rate;Wisconsin children's Hospital sedation scale score,CHW??;Awakening time;PACU dwell time;pediatric anesthesia emergence delirium,PAED;FUNK neurobehavioral score;

Secondary

MeasureTime frame
Operation time;Postoperative adverse reactions;Face, legs, activity, cry, consolability,FLACC;

Countries

China

Contacts

Public ContactMao Weiliang

Huzhou First People's Hospital

1554159820@qq.com+86 159 0672 8970

Outcome results

None listed

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