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Pharmacokinetics of esketamine in Chinese pediatric patients

Pharmacokinetics of esketamine in Chinese pediatric patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039529
Enrollment
Unknown
Registered
2020-10-30
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

Pharmacokinetics

Interventions

experimental group:1mg/kg esketamine intravenous injection

Sponsors

Women and Children's Hospital, School of Medicine, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. ASA score ranged from I to II; 2. Aged 2 to 5 years pediatric patient; 3. Weight 9.0 to 20.0 kg; 4. Operation time 24 h; 5. Patient is undergoing hypospadias surgery or lower extremity surgery; 6. To be able to good communication with researchers, and signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. The pediatric patient or the guardian or family members refuse; 2. History of fever, cough, sputum and asthma within 14 days before surgery; 3. Examination before anesthesia shows obvious secretions in the nasal cavity; 4. Severe heart, liver and kidney dysfunction; 5. Pediatric patient with congenital or genetic diseases; 6. Allergy to narcotic drugs; 8. Unable to cooperate with the test.

Design outcomes

Primary

MeasureTime frame
the plasma concentration of esketamine;the plasma concentration of S-demethylation ketamine;

Secondary

MeasureTime frame
BP, HR, RR, SpO2;recovery time;restlessness during recovery;adverse reaction;body movement;

Countries

China

Contacts

Public ContactLiao Yicong

Women and Children's Hospital, School of Medicine, Xiamen University

292066066@qq.com+86 15805925700

Outcome results

None listed

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