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A study on the ED90 of esketamine for preoperative sedation in children with left-to-right shunt congenital heart disease

A study on the ED90 of esketamine for preoperative sedation in children with left-to-right shunt congenital heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127601
Enrollment
Unknown
Registered
2026-07-02
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

congenital heart disease, CHD

Interventions

Toddler group (1 to 3 years):Esketamine is administered intranasally for preoperative sedation
Infant group (6 months to 1 year):Esketamine is administered intranasally for preoperative sedation
toddler group (1 to 3 years):Esketamine is administered intranasally for preoperative sedation

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Children with left-to-right shunt congenital heart disease who undergo elective surgery under general anesthesia, male or female; 2.ASA II-III; 3.Age is 6 months ~ 6 years old;

Exclusion criteria

Exclusion criteria: 1.The child's guardian refuses to participate; 2.Allergy to esketamine; 3.The child has abnormal nasal anatomy or intranasal bleeding; 4.The child had abnormal liver and kidney function; 5.The child has abnormal cardiac function; 6.Use of other sedative medications before surgery;

Design outcomes

Primary

MeasureTime frame
Calming effect;Calming effect;

Secondary

MeasureTime frame
heart rate;Respiratory rate;Oxygen saturation;Non-invasive blood pressure;

Countries

China

Contacts

Public ContactLifei Liu

Children's Hospital of Chongqing Medical University

54099645@qq.com+86 23 6363 2143

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026