Skip to content

Effects of Esketamine on Postoperative Anxiety and Depression in Adolescent Patients Undergoing Microtia Reconstruction: A Randomized Controlled Trial

Effects of Esketamine on Postoperative Anxiety and Depression in Adolescent Patients Undergoing Microtia Reconstruction: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110622
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Postoperative Anxiety and Depression

Interventions

Intervention Group:Esketamine (0.25 mg/kg) will be administered intravenously at anesthesia induction, followed by a second dose (0.125 mg/kg) 30 minutes before the end of surgery.
Control Group:The control group will receive a placebo (normal saline) at the same time points. The placebo will be matched to the esketamine formulation in appearance, volume, and route of administra

Sponsors

Tongji University School of medicine, Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. 12 years < Age < 18 years; 2. American Society of Anesthesiologists (ASA) physical status I or II; 3. No significant congenital systemic diseases; 4. No known allergy to esketamine or its excipients; 5. Willing to participate and provide written informed assent (by the participant) and consent (by a parent or legal guardian).

Exclusion criteria

Exclusion criteria: 1. History of severe psychiatric or neurological disorders that would impair cooperation; 2. Significant congenital diseases affecting major organs (e.g., heart, lung, brain, kidney) ; 3. Presence of active respiratory tract infection within recent weeks (e.g., 2-4 weeks prior to surgery) ; 4. Known hypersensitivity or allergy to esketamine or its excipients; 5. Pre-existing diagnosis of anxiety or depression requiring pharmacological treatment.

Design outcomes

Primary

MeasureTime frame
Postoperative Anxiety ;Postoperative Depression;

Secondary

MeasureTime frame
Opioid use;VAS score;adverse reaction;

Countries

China

Contacts

Public ContactZhonghua Ji

Tongji University School of medicine, Shanghai East Hospital

jzh20091125@163.com+86 138 2308 3858

Outcome results

None listed

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