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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
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A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine group | Experimental | Patients who undergo general anesthesia using esketamine. |
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| Control group | Placebo Comparator | Patients who undergo general anesthesia without esketamine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine 0.3mg/kg | Drug | A single dose of 0.3 mg/kg esketamine is administered intravenously during anesthesia induction, with the infusion completed over 40 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative anxiety and depreession | 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. | Preoperative day 1, postoperative day 3, day 7 and day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Sleep Quality | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood pressure | Intraoperative blood pressure#MAP in mmHg/SBP in mmHg/DBP in mmHg) at T0 (before induction of anesthesia), T1 (5 min after esketamine or control infusion), T2 (30 min after esketamine or control infusion), T3 (1 h after esketamine or control infusion), T4 (3 h after esketamine or control infusion), and T5(at the end of surgery) were included. | During the surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WEIDONG MI | Contact | 133810829 | wwdd1962@163.com | |
| Weidong Mi Mi | Contact | 13381082966 | wwdd1962@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Medical center of Chinese PLA General Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | Receiving the same volume of normal saline during induction of anesthesia during the same time |
|
| postoperative day 3, day 7 and day 30 |
| Delirium | 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. | Within 7 days after surgery] |
| PONV | 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). | Within 2 days after extubation |
| Postoperative Recovery Quality | 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 day 3,day 7 and day 30 |
| Postoperative Pain | 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 day 3,day 7 and day 30 |
| Postoperative Quality of Life | 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. | Postoperative day 3,day 7 and day 30 |
| Intraoperatively heart rate | Intraoperative heart rate#HR in bmp) at T0 (before induction of anesthesia), T1 (5 min after esketamine or control infusion), T2 (30 min after esketamine or control infusion), T3 (1 h after esketamine or control infusion), T4 (3 h after esketamine or control infusion), and T5(at the end of surgery) were included. | During the surgery |
| Perioperative inflammatory factor (IL-6) | Inflammatory factor (IL-6 in pg/ml) were from laboratory tests in the patient's medical record. | perioperatively |
| Perioperative inflammatory factor (CRP) | Inflammatory factor (CRP in mg/dl) were from laboratory tests in the patient's medical record. | perioperatively |
| Perioperative brain injury-related factor (S100β) | Brain injury-related factor (S100β in ng/ml) | perioperatively |
| Perioperative brain-derived neurotrophic factor (BDNF) | Brain-derived neurotrophic factor (BDNF in ng/ml) | perioperatively |
| Perioperative acetylcholine (Ach) | Acetylcholine (Ach in ng/ml) | perioperatively |
| Perioperative norepinephrine (NE) | Norepinephrine(NE in ng/ml) | perioperatively |
| D009369 |
| Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |