Clinical trial · Interventional
Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression
Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression: A Randomized Controlled Trial
NCT07374198CI-TRIAL-00101819not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients with Mild-to-Severe Depression
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Depression | — | UNRESOLVED | — |
| S-ketamine | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esketamine 0.3mg/kg | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Esketamine group
- description
- Patients who undergo general anesthesia using esketamine.
- interventionNames
- Drug: Esketamine 0.3mg/kg
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Patients who undergo general anesthesia without esketamine
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- Perioperative anxiety and depreession
- timeFrame
- Preoperative day 1, postoperative day 3, day 7 and day 30
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Scheduled to undergo elective breast cancer resection surgery. 3. American Society of Anesthesiologists (ASA) physical status classification of I-III. 4. Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form. 5. Female patients with mild to severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥8) 6. Anticipated anesthesia duration greater than 90 minutes. Exclusion Criteria: 1. Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders . 2. Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use . 3. Patients with an MMSE score \<18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) . 4. Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) . 5. Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) . 6. Patients with elevated intracranial or intraocular pressure. 7. Patients with untreated or inadequately treated hyperthyroidism . 8. Patients with a known allergy to the drugs involved in this study . 9. Patients unable to complete the assessment scales required by this study. 10. Patients who are currently participating in other clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.