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

N/ANot Yet RecruitingNCT07374198

Chinese PLA General Hospital142 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

142

Conditions

Depression Anxiety S-ketamine Breast Cancer

Interventions

Esketamine 0.3mg/kgDRUG

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

normal salineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Preoperative day 1, postoperative day 3, day 7 and day 30

Secondary Outcomes

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).

Time frame: Preoperative day 1, postoperative day 3, day 7 and day 30]

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.

Central Contacts

WEIDONG MI

CONTACT

133810829 wwdd1962@163.com

Weidong Mi Mi

CONTACT

13381082966 wwdd1962@163.com

Data from ClinicalTrials.gov

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