Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Depressive symptoms remission
研究概览
简要总结
Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective major surgery
- •Ages between 18 and 65 years old
- •Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
- •Signed informed consent
排除标准
- •had aphasia or any conditions that prevented mental health assessments,
- •had a history of psychotic or bipolar disorder,
- •had a comorbidity that affected hormone levels,
- •required prolonged postoperative mechanical ventilation,
- •had received treatment with antidepressants within 2 weeks prior to the screening,
- •had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points.
- •had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3),
- •had experienced adverse reactions to ketamine or esketamine,
- •had known drug use disorders,
- •pregnant or breastfeeding
研究组 & 干预措施
Placebo
干预措施: Normal saline (Drug)
Esketamine
干预措施: Esketamine (Drug)
结局指标
主要结局
Depressive symptoms remission
时间窗: Postoperative 3-day
Remission is defined as the Montgomery-Åsberg Depression Rating Scale (MADRS) total score no more than 10, MADRS is a sensitive tool used for tracking improvement or progression in patients with major depressive disorder, consisting of 10 items that jointly assess the degree of depressive symptoms.
次要结局
- MADRS scores(Postoperative 3-day)
- Side-effects and Adverse events(During surgery or up to 7 days after surgery)
- Depressive symptoms response(Postoperative 3-day)
- Moderate-to-severe pain(postoperative 3-day)
- Long-term patient outcome(1, 3, and 6 months after surgery)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital