Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

Conditions
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Depression

Intervention / Treatment
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* Drug: Esketamine
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least18 years and pre-menopausal; scheduled to undergo elective breast cancer operation; American Society of Anaesthesiologists (ASA) risk classification I-II. Montgomery-asberg Depression Rating Scale (MADRS) score ≥22 Exclusion Criteria: Cognitive difficulties Partial or complete gastrectomy Previous esophageal surgery Inability to conform to the study's requirements Ongoing participation or participation in another study <1 month ago

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline. | Drug: Saline Solution<br>* All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.<br>|
| Active Comparator: Esketamine<br>All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine. | Drug: Esketamine<br>* All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-asberg Depression Rating Scale score | Changes of Montgomery-asberg Depression Rating Scale score | from baseline to postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | from baseline to postoperative 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, sleep deprivation, gut microbiota, bispectral index