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.
Normal Saline: Receiving the same volume of normal saline during induction of anesthesia during the same time
Study summary
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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. 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
Primary outcome measure(s)
Perioperative anxiety and depreession — Preoperative day 1, postoperative day 3, day 7 and day 30 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 (HADS-A) 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.
Trial sites (1)
Facility
City
Region
Status
First Medical center of Chinese PLA General Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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