Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Se… (NCT07374211) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Severe Depression
242 participantsStarted 2026-01-18
Plain-language summary
This project employs a prospective, randomized, controlled, blinded, dual-center study design to investigate the effects of intraoperative esketamine on perioperative anxiety and depression symptoms in patients with severe depression undergoing breast cancer surgery.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years.
✓. Scheduled to undergo elective breast cancer resection surgery.
✓. American Society of Anesthesiologists (ASA) physical status classification of I-III.
✓. Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form.
✓. Female patients with severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥15)
✓. Anticipated anesthesia duration greater than 90 minutes.
Exclusion criteria
✕. Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders .
✕. Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use .
✕. Patients with an MMSE score \<18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) .
✕. Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) .
✕. Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) .
✕. Patients with elevated intracranial or intraocular pressure.
What they're measuring
1
Perioperative anxiety and depreession
Timeframe: Preoperative day 1, postoperative day 3 ,day 7 and day 30