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临床试验/NCT02509949
NCT02509949Unknown4 期

Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients

Tao Zhang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
Postoperative Delirium

研究概览

简要总结

Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions.

One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital.

Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age > 17 and < 60 years;
  • American Society of Anesthesiology (ASA) I-III;
  • admitted for living donor renal transplantation.

排除标准

  • Patients with a history of drug abuse;
  • preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).

研究组 & 干预措施

Dexmedetomidine

Experimental

Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation.

干预措施: Dexmedetomidine (Drug)

Saline

Placebo Comparator

Saline ivpump 0.2ug/kg/h during living donor renal transplantation.

干预措施: Saline (Drug)

结局指标

主要结局

Postoperative Delirium

时间窗: Postoperative day 1-7.

次要结局

未报告次要终点

研究者

发起方
Tao Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tao Zhang

Tao Zhang

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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