Effect of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery

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

NCT07367542

PLAGH-RCT-Esket-Breast Cancer

Details and patient eligibility

About

A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery

Enrollment: 218 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. 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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218 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