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Study on the application of esketamine in comfort technique before anesthesia in children

Study on the application of esketamine in comfort technique before anesthesia in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050802
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-09-06
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Pediatric anesthesia

Interventions

Control group:Not receiving any sedative drugs
Midazolam group:Midazolam 0.1mg/kg
Low-dose esketamine group:Low-dose esketamine 0.3mg/kg
Medium-dose esketamine group:Medium-dose esketamine 0.5mg/kg
High-dose esketamine group:High-dose esketamine 0.7mg/kg

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1-6 years; 2. ASA classification I-II; 3. Elective non-cardiac surgery under general anesthesia; 4. Parents voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Unconsciousness; 2. Nervous system diseases; 3. Received sedation treatment 72 hours before surgery; 4. Intellectual deficiency; 5. Failure to open venous access before surgery; 6. Needle phobia; 7. Neurosurgery; 8. EEG detection cannot be achieved in maxillofacial surgery; 9. Liver insufficiency; 10. Participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Sedation score;

Secondary

MeasureTime frame
Anxiety score;Motor assessment scale (MAS);Mean arterial pressure;Heart rate;SpO2;Face, legs, activity, cry and consolability pain scale (FLACC score);Resuscitation assessment;Adverse reactions;Electroencephalogram (EEG);

Countries

China

Contacts

Public ContactYang Yitian

He'nan Provincial People's Hospital

yangyitiansdu@126.com+86 13007617066

Outcome results

None listed

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