Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium.
研究概览
简要总结
Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's Disease
- •Exist non-motor symptoms
- •Undergoing selective DBS.
- •Age ≥60 years.
- •Obtain written informed consent.
排除标准
- •preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18)
- •history of psychoactive
- •allergic or intolerant to dexmedetomidine
- •severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block
- •severe hepatic dysfunction (Child-Pugh class C)
- •severe renal dysfunction requiring renal replacement therapy before the surgery
- •medical records documented inability to communicate in the preoperative period due to language barrier or other situations.
研究组 & 干预措施
DEX group
Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.
干预措施: Dexmedetomidine (Drug)
Placebo group
The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
The incidence of postoperative delirium.
时间窗: Postoperative 5 days
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
次要结局
- Quality of sleep(the second and the third day after surgery)
- Postoperative pain(within 3 days after surgery.)
- Quality of recovery.(First day after surgery)
- The severity of postoperative delirium.(Postoperative 5 days)
- Cognitive function(before surgery and 5 days after surgery)
- Anxiety and depression(before surgery and 5 days after surgery)
- Parkinson's disease related status(before surgery and 5 days after surgery)
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital