Status:
RECRUITING
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Lead Sponsor:
China Medical University, China
Conditions:
Depression
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomi...
Detailed Description
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 anesth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04303325
Start Date
October 8 2021
End Date
December 30 2024
Last Update
July 22 2024
Active Locations (1)
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1
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001