Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression

NCT07374198 | Not Yet Recruiting

• 1 other identifier: PLAGH-RCT-Esket-MTOSBC
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Depression; Anxiety; S-ketamine; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Perioperative anxiety and depreession

  Perioperative anxiety and depreession The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.

  Preoperative day 1, postoperative day 3, day 7 and day 30

Secondary Outcomes (6)

• Postoperative Sleep Quality

  Preoperative day 1, postoperative day 3, day 7 and day 30]

• Delirium

  Within 7 days after surgery

• PONV

  Within 2 days after extubation

• Postoperative Recovery Quality

  Postoperative day 3, day 7 and day 30

• Postoperative Pain

  Postoperative day , day 7 and day 30

Other Outcomes (7)

• Intraoperative blood pressure

  During the surgery

• Intraoperatively heart rate

  During the surgery

• Perioperative inflammatory factor (IL-6) Inflammatory factor (IL-6 in pg/ml) were f

  perioperatively

Study Arms (2)

Esketamine group

EXPERIMENTAL

Patients who undergo general anesthesia using esketamine.

Drug: Esketamine 0.3mg/kg

Control group

PLACEBO COMPARATOR

Patients who undergo general anesthesia without esketamine

Drug: normal saline

Interventions

Esketamine 0.3mg/kg DRUG

A single intravenous bolus of 0.3 mg/kg of esketamine is administered during anesthesia induction, and the infusion is completed over 40 minutes.

Esketamine group

normal saline DRUG

Receiving the same volume of normal saline during induction of anesthesia.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 mild to severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥8)
• Anticipated anesthesia duration greater than 90 minutes.

You may not qualify if:

• 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.
• Patients with untreated or inadequately treated hyperthyroidism .
• Patients with a known allergy to the drugs involved in this study .
• Patients unable to complete the assessment scales required by this study.
• Patients who are currently participating in other clinical trials

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders; Breast Neoplasms

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

WEIDONG MI

CONTACT

133810829; wwdd1962@163.com

Weidong Mi Mi

CONTACT

13381082966; wwdd1962@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 28, 2026
• Study Start: January 18, 2026
• Primary Completion: January 18, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share