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This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.
For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline. |
|
| Esketamine | Active Comparator | All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-asberg Depression Rating Scale score | Changes of Montgomery-asberg Depression Rating Scale score | from baseline to postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bispectral index | Changes of bispectral index data | from 8pm to 6am on the first postoperative night |
| Gut microbiota | changs of gut microbiota |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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Parallel Assignment
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| Saline Solution | Drug | All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline. |
|
| from baseline to postoperative 72 hours |
| ID | Term |
|---|---|
| D003863 | Depression |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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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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