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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Breast Cancer; Anxiety; S-ketamine
• Intervention / Treatment: Drug: normal saline; Drug: Esketamine 0.3mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WEIDONG MI; Phone Number: 133810829; Email: wwdd1962@163.com
• Study Contact Backup: Name: Weidong Mi Mi; Phone Number: 13381082966; Email: wwdd1962@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esketamine group; Patients who undergo general anesthesia using esketamine.	Drug: Esketamine 0.3mg/kg; A single intravenous bolus of 0.3 mg/kg of esketamine is administered during anesthesia induction, and the infusion is completed over 40 minutes.
Placebo Comparator: Control group; Patients who undergo general anesthesia without esketamine	Drug: normal saline; Receiving the same volume of normal saline during induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Delirium was assessed using a combination of the 3-Minute Diagnostic Interview for CAM (3D-CAM) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patients in the general ward were assessed using the 3D-CAM, while patients in the intensive care unit were assessed using the CAM-ICU. Delirium consists of four main features: acute altered mental status or fluctuating level of consciousness, inattention, disorganized thinking, and altered level of consciousness. Patients were diagnosed with postoperative delirium if both the first and second features were present, and either the third or fourth feature was also present.	Within 7 days after surgery
PONV	Postoperative nausea and vomiting (PONV) were assessed using a visual analogue scale (VAS). This scale consists of a 10-centimeter straight line, with 0 indicating no nausea and vomiting, and 10 indicating the most extreme level of nausea and vomiting that can be endured. The severity of PONV is categorized as follows: mild (1 to 4), moderate (5 to 6), and severe (7 to 10).	Within 2 days after extubation
Postoperative Quality of Life	Postoperative quality of life was assessed using the EuroQol 5-Dimension questionnaire (EQ-5D). This instrument evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For the descriptive system, each dimension is typically rated using a three-level scale (no problems, some problems, extreme problems) or a five-level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).The responses are combined to form a 5-digit health state profile (e.g., 11111 for no problems in any dimension). This profile is then converted into a single summary number called the EQ-5D index score, using a country-specific value set. The theoretical range of the index score is approximately from -0.594 (worst imaginable health state, considered worse than death) to 1.0 (perfect health), with 0 representing a health state equivalent to death. Therefore, a higher EQ-5D index score indicates a better quality of life.	Postoperative day 3,day 7 and day 30
Postoperative Sleep Quality	Postoperative sleep quality was assessed using the Insomnia Severity Index (ISI). The ISI is a simple tool used to screen for insomnia and consists of 7 items to assess the nature and symptoms of the subject's sleep disorder on a 5-point Likert scale, with each item scored from 0 to 4 and the total score ranging from 0 to 28, with higher scores indicating greater severity of insomnia. The sum of the scores with 0-7 indicating insomnia without clinical significance, 8-14 indicating subclinical insomnia, 15-21 indicating clinical insomnia (moderate), 22-28 indicating 'clinical insomnia (moderate), and 22-28 indicating clinical insomnia (moderate). A score of 8 to 14 indicates subclinical insomnia, a score of 15 to 21 indicates clinical insomnia (moderate), and a score of 22 to 28 indicates clinical insomnia (severe).	Preoperative day 1, postoperative day 3, day 7 and day 30]
Postoperative Recovery Quality	Postoperative quality of recovery was evaluated using the Chinese version of the Quality of Recovery-15 (QoR-15) score. This assessment tool comprises 15 items, each scored on a 10-point scale. The total score ranges from 0 to 150, with 0 indicating poor recovery and 150 signifying an excellent quality of recovery.	Postoperative day 3, day 7 and day 30
Postoperative Pain	Assessment was conducted using the Numerical Rating Scale (NRS) for pain, which ranges from 0 to 10. On this scale, a score of 0 represents the absence of pain, while a score of 10 represents the most severe pain.	Postoperative day , day 7 and day 30

Other Outcome Measures

Outcome Measure	Time Frame
Intraoperative blood pressure	During the surgery
Intraoperatively heart rate	During the surgery
Perioperative brain injury-related factor (S100β)	perioperatively
Perioperative acetylcholine (Ach)	perioperatively
Perioperative norepinephrine (NE)	perioperatively
Perioperative inflammatory factor (IL-6) Inflammatory factor (IL-6 in pg/ml) were f	perioperatively
Perioperative inflammatory factor (CRP)	perioperatively

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 18, 2026
• Primary Completion (Estimated): January 18, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Behavioral Symptoms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Anxiety Disorders; Depression; Breast Neoplasms; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Esketamine; Saline Solution
• Other Study ID Numbers: PLAGH-RCT-Esket-MTOSBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No