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临床试验/NCT01681238
NCT01681238Unknown不适用

A Randomized Study of Goal-directed Therapy in the Elderly High-risk Patients Undergoing Total Hip Replacement

Guangzhou First People's Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
length of postoperative hospital stay

研究概览

简要总结

There is growing evidence that the risk of postoperative complications can be decreased by optimizing the amount and type of infusion fluids given during surgery, steered by goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk patients. This study is undertaken subsequently to test the hypothesis that the intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor, can partially prevented postoperative complications and shorten hospital stay in the elderly high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .

详细描述

After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences, Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic (body temperature > 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to different protocol group according to the study arm to which the patient allocated.Postoperative care and discharge criteria were predefined using the hospital care map and protocol.

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, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Adult patients scheduled for total hip replacement at this institution.
  • American Society of Anaesthesiologists (ASA) physical status of III or VI.
  • Two or more risk factors according to risk index of Lee .

排除标准

  • Age under 70years old
  • idiopathic coagulopathy: with warfarin or heparin
  • systemic or local infection
  • unable to cooperate
  • spinal trauma or severe low back pain history
  • patient refusal.

结局指标

主要结局

length of postoperative hospital stay

时间窗: 28 days

days from end of surgery to hospital discharge.

次要结局

  • postoperative complications and mortality(28 days)

研究者

发起方
Guangzhou First People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangcai Ruan

Professor, Vice Chair

Guangzhou First People's Hospital

研究点 (1)

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