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Efficacy of Esketamine for Preventing Postoperative Negative Behaviors in Pediatric Ophthalmic Day Surgery: A Single-Center, Double-Blind, Randomized Controlled Trial

Efficacy of Esketamine for Preventing Postoperative Negative Behaviors in Pediatric Ophthalmic Day Surgery: A Single-Center, Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123621
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Postoperative negative behaviors

Interventions

Esketamine Group (EKM Group):Esketamine 0.3 mg/kg intravenously administered 15 minutes before the end of surgery
Saline Group (SAL Group):Normal saline 0.1 ml/kg intravenously administered 15 minutes before the end of surgery

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1:elective ophthalmic surgery under general anesthesia with an estimated operative time not exceeding 2 hours; 2:age 6–12 years; 3: American Society of Anesthesiologists (ASA) physical status I–II; 4: agreement to participate in the trial and voluntary signed informed consent.

Exclusion criteria

Exclusion criteria: 1:Allergy or contraindication to esketamine or any of its components; 2:Upper respiratory tract infection within the past 14 days; 3: Premature birth, or history of congenital, genetic, psychiatric diseases, or epilepsy; 4:Presence of intellectual disability or cognitive dysfunction before surgery; 5: Congenital heart disease, abnormal liver or kidney function, glaucoma, or elevated intraocular pressure

Design outcomes

Primary

MeasureTime frame
The incidence of emergence delirium during the anesthesia recovery period.;

Secondary

MeasureTime frame
Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) score;Children's Sleep Habits Questionnaire (CSHQ) score;PAED scores at different time points during the anesthesia recovery period.;Incidence of postoperative complications in the PACU and within 24 hours postoperatively;

Countries

China

Contacts

Public ContactGan Xiaoliang

Zhongshan Ophthalmic Center, Sun Yat-sen University

ganxl@mail.sysu.edu.cn+86 136 8889 3908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026