The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of participants with postoperative neurological complications
研究概览
简要总结
Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
- •age between 20 to 80 yr
排除标准
- •Fever, elevated white blood cell or C-reactive protein
- •Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
- •Impaired renal function, cGFR< 60 ml/min/1.73 m2
- •Cardiac dysfunction, such as heart failure > NYHA class II
研究组 & 干预措施
DEX
Intraoperative intravenous infusion of dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Control
Intraoperative intravenous infusion of 0.9% saline
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Number of participants with postoperative neurological complications
时间窗: during postoperative period of hospital admission, approximately 10 days by estimation
次要结局
- Number of participants with postoperative delirium(during postoperative period of hospital admission, approximately 10 days by estimation)
- Serum biomarkers changes(Between preoperative baseline and postoperative day one.)
- Intraoperative haemodynamic profile(during intraoperative perioid, approximately 4-6 hours by estimation)