Cerebral Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative minimal hepatic encephalopathy (MHE)
研究概览
简要总结
The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.
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
- Double (Participant, 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
- •Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.
- •Sign the informed consent
排除标准
- •The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.
- •Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.
- •With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.
- •Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.
研究组 & 干预措施
Selective Head Cooling
Participants received a cooling helmet filled with ice water mixture after an-esthesia induction until the end of the surgery.
干预措施: Cooling Helmet (Device)
Dexmedetomidine
Giving dexmedetomidine1μg/kg i.v for 10 minutes, then use computerized infusion pump at 0.5μg/kg.h until the end of the surgery.
干预措施: Dexmedetomidine (Drug)
Selective Head Cooling and Dexmedetomidine
Using selective head cooling combined with dexmedetomidine as described before
干预措施: Dexmedetomidine (Drug)
Selective Head Cooling and Dexmedetomidine
Using selective head cooling combined with dexmedetomidine as described before
干预措施: Cooling Helmet (Device)
结局指标
主要结局
Postoperative minimal hepatic encephalopathy (MHE)
时间窗: 14 days after surgery
Using PSE-Syndrom-Test
次要结局
未报告次要终点
研究者
Huawei He
Postgraduate
Huazhong University of Science and Technology