Anxiety, Breast Cancer, Depression, S-ketamine
Conditions
Brief summary
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery
Interventions
A single dose of 0.3 mg/kg esketamine is administered intravenously during anesthesia induction, with the infusion completed over 40 minutes.
DRUGNormal Saline
Receiving the same volume of normal saline during induction of anesthesia during the same time
Sponsors
Chinese PLA General Hospital
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Sleep Quality | postoperative day 3, day 7 and day 30 | 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). |
| Delirium | Within 7 days after surgery] | 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. |
| PONV | Within 2 days after extubation | Postoperative nausea and vomiting (PONV) were assessed using a visual analogue scale (VAS). This scale consists of a 10-centimeter straight line, with 0 indicating no nausea and vomiting, and 10 indicating the most extreme level of nausea and vomiting that can be endured. The severity of PONV is categorized as follows: mild (1 to 4), moderate (5 to 6), and severe (7 to 10). |
| Postoperative Recovery Quality | Postoperative day 3,day 7 and day 30 | Postoperative quality of recovery was evaluated using the Chinese version of the Quality of Recovery-15 (QoR-15) score. This assessment tool comprises 15 items, each scored on a 10-point scale. The total score ranges from 0 to 150, with 0 indicating poor recovery and 150 signifying an excellent quality of recovery |
| Postoperative Pain | Postoperative day 3,day 7 and day 30 | Assessment was conducted using the Numerical Rating Scale (NRS) for pain, which ranges from 0 to 10. On this scale, a score of 0 represents the absence of pain, while a score of 10 represents the most severe pain. |
| Postoperative Quality of Life | Postoperative day 3,day 7 and day 30 | Postoperative quality of life was assessed using the EuroQol 5-Dimension questionnaire (EQ-5D). This instrument evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For the descriptive system, each dimension is typically rated using a three-level scale (no problems, some problems, extreme problems) or a five-level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).The responses are combined to form a 5-digit health state profile (e.g., 11111 for no problems in any dimension). This profile is then converted into a single summary number called the EQ-5D index score, using a country-specific value set. The theoretical range of the index score is approximately from -0.594 (worst imaginable health state, considered worse than death) to 1.0 (perfect health), with 0 representing a health state equivalent to death. Therefore, a higher EQ-5D index score indicates a better quality of life. |
Countries
China
Contacts
CONTACTWEIDONG MI
CONTACTWeidong Mi Mi
Outcome results
None listed