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Not yet recruiting NCT07374211

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

No phase Interventional Depression Anxiety S-ketamine Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine 0.3mg/kg, normal saline.
Who it may be relevant to
Registry conditions: Depression, Anxiety, S-ketamine, Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Severe Depression: A Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Perioperative anxiety and depreession [Time frame: Preoperative day 1, postoperative day 3 ,day 7 and day 30]
Secondary outcome measures (6)
  • Postoperative Sleep Quality [Time frame: Preoperative day 1, postoperative day 3 ,day 7 and day 30]
  • Delirium [Time frame: Within 7 days after surgery]
  • PONV [Time frame: Within 2 days after extubation]
  • Postoperative Recovery Quality [Time frame: Postoperative day 3 ,day 7 and day 30]
  • Postoperative Pain [Time frame: Postoperative day 3 ,day 7 and day 30]
  • Postoperative Quality of Life [Time frame: postoperative day 3 ,day 7 and day 30]

Eligibility criteria

Inclusion criteria

  • 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 severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥15)
  • Anticipated anesthesia duration greater than 90 minutes.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07374211 · PLAGH-RCT-Esket-SBreastCancer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗