Actively Recruiting
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Led by China Medical University, China · Updated on 2024-07-22
72
Participants Needed
1
Research Sites
168 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients at least 18 years old and pre-menopausal
- Scheduled for elective breast cancer surgery
- Classified as American Society of Anaesthesiologists (ASA) risk I or II
- Montgomery-Asberg Depression Rating Scale (MADRS) score of 22 or higher
You will not qualify if you...
- Cognitive difficulties
- Partial or complete removal of the stomach (gastrectomy)
- Previous surgery on the esophagus
- Unable to follow the study requirements
- Currently participating in another study or participated within the last month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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