Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.
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
- •Brain tumor located supratentorial area and need to receive elective craniotomy;
- •Moderate to severe depressive symptom measured by the qualified psychiatric doctors.
- •Ages between 18 and 65 years old.
- •American Society of Anesthesiologists physical status I-III
排除标准
- •History of epilepsy;
- •Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.
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
Response rate
时间窗: Postoperative 3 days
≥50% reduction in MADRS scores from baseline value.The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression.
次要结局
- The remission rate(Postoperative 3 days and discharge.)
- Anxiety symptom(Postoperative 3 days.)
- Postoperative delirium(Postoperative 1 day.)
- Severe pain(Postoperative 3 days.)
- Postoperative 30-day quality of life reported by KPS(Postoperative 30 days)
- Psychiatric outcomes and complications(Postoperative 3 days and discharge.)
研究者
Yuming Peng
Associate professor
Beijing Tiantan Hospital