Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Se… (NCT07374211) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Severe Depression
242 participantsStarted 2026-01-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative anxiety and depreession
Timeframe: Preoperative day 1, postoperative day 3 ,day 7 and day 30