Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- QoR40 score
研究概览
简要总结
Breast cancer patients often have perioperative emotional disorders such as anxiety and depression, which can lead to poor quality of recovery.This study aims to determine whether ketamine could improve the quality of recovery in breast cancer patients. Meanwhile, it will show if ketamine could improve anxiety, depression, postoperative pain and fatigue.This trial also will bring great concerns on patients' mental health perioperatively and explore the measures to improve their quality of life.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Grade I-II
- •Patients undergoing elective breast cancer surgery under general anesthesia
排除标准
- •Unstable hypertension, history of heart disease
- •Hepatic or renal dysfunction
- •Patients undergoing chemotherapy before surgery
- •Have a history of chronic pain or chronic use of analgesic
- •Have mental illness or can't cooperate with investigators
- •Have a history of ketamine allergy
研究组 & 干预措施
ketamine group
干预措施: ketamine (Drug)
normal saline group
干预措施: Normal saline (Drug)
结局指标
主要结局
QoR40 score
时间窗: the first day after surgery
Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
次要结局
- HADS scores(Postoperative 2 days and 3months)
- Chronic Pain(3 months after surgery)
- ICFS scores(Postoperative 3 days, 7 days and 30 days)
- NRS pain scores(at 4 hours, 24 hours, and 48 hours after surgery)
- Postoperative complications(Postoperative 1 day, 2 days and 3 days)
研究者
Han Yuan
Doctor-in-charge of Anesthetist
Xuzhou Medical University