跳至主要内容
临床试验/NCT02793986
NCT02793986已完成不适用

Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

The First Affiliated Hospital of Anhui Medical University1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
296
试验地点
1
主要终点
Incidence of postoperative delirium

研究概览

简要总结

With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years or older and undergoing hip fracture repair

排除标准

  • Patients with severe cognitive impairment (MMSE score, <15)
  • Preoperative delirium as determined by Confusion Assessment Method
  • Contraindications to local anesthesia
  • Prior hip surgery
  • Mental or language barriers that would preclude data collection
  • Severe congestive heart failure (NewYork Heart Association class IV)
  • Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)

研究组 & 干预措施

dexmedetomidine sedation

Experimental

Patients received local anesthesia, in this arm, the sedation of patients was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h.

干预措施: dexmedetomidine (Drug)

propofol sedation

Experimental

Patients received local anesthesia, in this arm, the sedation of patients was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.

干预措施: propofol (Drug)

结局指标

主要结局

Incidence of postoperative delirium

时间窗: 7 days after surgery

Mortality in 30 days after surgery

时间窗: 30 days after surgery

次要结局

  • Complications of cardiopulmonary system(30 days after surgery)
  • Incidence of cerebrovascular accident(30 days after surgery)
  • Dosage of vasoactive agent(During sugary)
  • Discharge time(30 days after surgery)
  • Hemodynamic index(intraoperative)
  • Extubation time(7 days after surgery)
  • Out of bed time(7 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验