The Effective Dose of Esketamine to Inhibit the Somatic Reaction during Sacral Canal Operation in Children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070462

Enrollment

Unknown

Registered

2023-04-12

Start date

2023-04-12

Completion date

Unknown

Last updated

2023-06-04

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

Conditions

Caudal Block

Interventions

s1 group:intravenous injection of 1.1ED95 Esketamine

s2 group:intravenous injection of 1.2ED95 Esketamine

s3 group:intravenous injection of 1.3ED95 Esketamine

S4 group:intravenous injection of 1.4ED95 Esketamine

Phase I group:the corresponding dose of esketamine was administered according to the method of the Dixon up and down sequential method test

Eligibility

Sex/Gender

All

Age

1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children requiring sacral block for elective surgery. 2. ASA grade I-II. 3. BMI 14-18kg/m^2. 4. Aged 1-7 years.

Exclusion criteria

Exclusion criteria: 1. Contraindications of sacral canal block. 2. Allergic history of Esketamine and local anesthesia drugs. 3. Upper respiratory tract infection one week before surgery. 4. Preoperative mental illness and mental retardation. 5. Preoperative liver and kidney function and heart disease. 6.10 minutes < Operation time <60 minutes.

Design outcomes

Primary

Measure	Time frame
Successful sacral block;	—

Secondary

Measure	Time frame
Blood pressure;Heart rate;SPO2;Awakening quality;Adverse effects (nausea, dreams, blurred vision, dizziness, more discharge);	—

Countries

China

Contacts

Public ContactDu Bing

Xuzhou Children's Hospital

dubing1686@163.com+86 13813491686

Outcome results

None listed

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