Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Beijing Tiantan Hospital
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium.
概览
简要总结
Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies 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 (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing selective awake craniotomies.
- •Age ≥18 years.
- •Obtain written informed consent.
排除标准
- •1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18).
- •2.Preoperative psychotropic medication within one year.
- •3.BMI≤18 or ≥30 Kg/ m2
- •4.Pregnant or lactating women.
- •5.History of traumatic brain injury or neurosurgery.
- •6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
- •7.Severe hepatic or renal dysfunction.
研究组 & 干预措施
Placebo group
The placebo group patients will be received 0.9% saline intraoperatively.
干预措施: 0.9% saline (Drug)
DEX group
The DEX group patients will be received dexmedetomidine intraoperatively.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The incidence of postoperative delirium.
时间窗: postoperative 5 day.
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
未报告次要终点
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital