The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression:A Prospective Radomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale ≥7
研究概览
简要总结
The aim of this study is to observe the antidepressant effect of low-dose esketamine in obese patients with preoperative depression and seeking bariatric surgery. We speculate that intraoperative infusion and the addition of a small dose of esketamine to the postoperative analgesic pump can help reduce the proportion of patients with depression after surgery, and may further improve postoperative recovery, reduce the use of postoperative opioids, shorten postoperative hospital stay, and improve postoperative quality of life of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and <65 years old
- •Patients with a BMI greater than 35 kg/m^2
- •Hamilton Depression score ≥7 points
- •Planned to undergo elective laparoscopic sleeve gastrectomy
排除标准
- •ASA ≥ grade IV
- •Those who have had or are currently suffering from mental disorders other than anxiety and depression, such as schizophrenia, bipolar disorder, organic mental disorders, etc.
- •Those who are unable to cooperate in completing the scale assessment
- •Have received ketamine/esketamine treatment, or are allergic to ketamine/esketamine
- •Clarify ischemic cardiomyopathy or severe liver and kidney dysfunction (Child pugh grade C, CKD stage G5)
- •People with opioid dependence and those who have been taking various types of painkillers for a long time (more than 3 months)
- •Participate in other research
研究组 & 干预措施
esketamine
干预措施: Esketamine (Drug)
dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Hamilton Depression Scale ≥7
时间窗: Seven days after the operation
The proportion of patients with depression (Hamilton Depression score ≥7)
次要结局
- the proportion of patients with depression(30 days, 3 months, 6 month and 1 year after the operation)
研究者
Zhiwen Li
study director
The First Hospital of Jilin University