Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Montgomery-asberg Depression Rating Scale score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
干预措施: 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.
干预措施: Esketamine (Drug)
结局指标
主要结局
Montgomery-asberg Depression Rating Scale score
时间窗: from baseline to postoperative 24 hours
Changes of Montgomery-asberg Depression Rating Scale score
次要结局
- Bispectral index(from 8pm to 6am on the first postoperative night)
- Gut microbiota(from baseline to postoperative 72 hours)
研究者
Wenfei Tan
Professor
China Medical University, China