Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
China Medical University, China
72 participants
Oct 8, 2021
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04303325