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临床试验/NCT02245256
NCT02245256已完成4 期

Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
217
试验地点
1
主要终点
analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.

研究概览

简要总结

To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the ICU.

Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation

排除标准

  • Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

研究组 & 干预措施

Normal saline

Placebo Comparator

same infusion rate as experimental group (dexmedetomidine)

干预措施: placebo control (Drug)

dexmedetomidine

Experimental

0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

干预措施: Precedex (Drug)

结局指标

主要结局

analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.

时间窗: 1 week or transfer to ward, whichever comes first.

after August 25, 2014

次要结局

  • analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.(1 week or transfer to ward, whichever comes first.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Geol Ryu

assistant professor

Seoul National University Hospital

研究点 (1)

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