Not yet recruiting NCT07367542
Effect of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery
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
- China
- 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 Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
Overview
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery
Interventions
- Drug Esketamine 0.3mg/kg
A single dose of 0.3 mg/kg esketamine is administered intravenously during anesthesia induction, with the infusion completed over 40 minutes. - Drug Normal Saline
Receiving the same volume of normal saline during induction of anesthesia during the same time
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: 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.
- 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
China · 1 center
- First Medical center of Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT07367542 · PLAGH-RCT-Esket-Breast Cancer