Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Severe Depression

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Breast Cancer; S-ketamine; Depression; Anxiety

Treatments: Drug: Esketamine 0.3mg/kg; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07374211

PLAGH-RCT-Esket-SBreastCancer

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥15)
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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242 participants in 2 patient groups, including a placebo group

Esketamine group

Experimental group

Description:

Patients who undergo general anesthesia using esketamine.

Treatment:

Drug: Esketamine 0.3mg/kg

Control group

Placebo Comparator group

Description:

Patients who undergo general anesthesia without esketamine

Treatment:

Drug: normal saline