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Efficacy of Pre-anesthetic Esketamine Injection on Postoperative Depression in Non-Cardiac Thoracic Surgery Patients: A Randomized Clinical Trial

Effects of Peri-Anesthetic Esketamine Administration Timing on Postoperative Depression in Non-Cardiac Thoracic Surgery Patients: A Randomized, Double-blind, Placebo-controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107302
Enrollment
Unknown
Registered
2025-08-08
Start date
2025-08-13
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Postoperative Depression

Interventions

Placebo group (Group 1):Intravenous injection of normal saline with corresponding volume before anesthesia + intravenous injection of normal saline with equal volume after anesthesia
Pre-anesthesia ES group (Group 2):Intravenous injection of 0.5 mg/kg esketamine before anesthesia + intravenous injection of normal saline with equal volume after anesthesia
Post-anesthesia ES group (Group 3):Intravenous injection of normal saline with equal volume before anesthesia + intravenous injection of 0.5 mg/kg esketamine after anesthesia

Sponsors

Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years, undergoing elective non-cardiac thoracic surgery; 2.Patients with mild to severe depressive symptoms preoperatively, i.e., PHQ-9 score > 4; 3.Surgery with an anticipated anesthesia duration > 120 minutes; 4.Undergoing the first elective general anesthesia surgery only during the current hospitalization; 5.ASA physical status classification ?-?; 6. Subjects who fully understand the benefits and risks of this trial, are willing to participate, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to NMDA receptor antagonists; 2.Current or past history of schizophrenia, bipolar disorder, or anesthetic abuse; 3.Uncontrolled hypertension (SBP > 160 mmHg/DBP > 100 mmHg) or extremely high risk in hypertension risk stratification; 4. Contraindications to esketamine use, such as risks of increased intraocular pressure or intracranial pressure (e.g., glaucoma, brain tumor, recent craniocerebral injury); 5. Pregnant or lactating women; 6.Inability or unwillingness to cooperate with questionnaires and clinical examinations; 7. Severe agitation or delirium before surgery; 8. Receiving antipsychotic treatment or having conditions requiring emergency psychiatric intervention before surgery (e.g., acute depressive episode, suicide risk, etc.); 9.Body mass index (BMI) > 30 kg/m^2.

Design outcomes

Primary

MeasureTime frame
17 item Hamilton depression rating scale(17-HAMD);

Secondary

MeasureTime frame
agitation;PACU delirium;adverse mental symptoms during the emergence period;17 item Hamilton depression rating scale(17-HAMD);postoperative sleep;postoperative pain;postoperative nausea and vomiting;postoperative opioid consumption;length of postoperative hospital stays and total hospital stays;EEG characteristics;Serum brain-derived neurotrophic factor levels;hs-CRP;To be determined blood test indicators;

Countries

China

Contacts

Public ContactOuyang Wen; Liu Xing; Chen Jia

Third Xiangya Hospital, Central South University

814361833@qq.com+86 137 5506 8024

Outcome results

None listed

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