Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Montgomery-asberg Depression Rating Scale score
Study Overview
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 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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Intervention: Saline Solution (Drug)
Esketamine
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.
Intervention: Esketamine (Drug)
Outcomes
Primary Outcomes
Montgomery-asberg Depression Rating Scale score
Time Frame: from baseline to postoperative 24 hours
Changes of Montgomery-asberg Depression Rating Scale score
Secondary Outcomes
- Bispectral index(from 8pm to 6am on the first postoperative night)
- Gut microbiota(from baseline to postoperative 72 hours)
Investigators
Wenfei Tan
Professor
China Medical University, China