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临床试验/NCT02458547
NCT02458547已完成不适用

Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients

Yonsei University1 个研究点 分布在 1 个国家目标入组 186 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
不适用
状态
已完成
入组人数
186
试验地点
1
主要终点
HMGB1

研究概览

简要总结

Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patients older than 65 years scheduled for elective or emergency hip fracture surgery.

排除标准

  • Patient refusal
  • Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
  • Allergies to propofol or its ingredients, soybeans or peanuts
  • Patients with altered mental status
  • Illiterate patients or foreigners

研究组 & 干预措施

Group S

Active Comparator

Spinal anesthesia with 0.5% bupivacaine

干预措施: Bupivacaine (Drug)

Group D

Experimental

General anesthesia with desflurane

干预措施: Desflurane (Drug)

Group P

Active Comparator

General anesthesia with propofol total intravenous anesthesia

干预措施: Propofol (Drug)

结局指标

主要结局

HMGB1

时间窗: from preoperative baseline to 72hours

IL-6

时间窗: from preoperative baseline to 72hours

NT-proBNP

时间窗: from preoperative baseline to 72hours

hemoglobin

时间窗: from preoperative baseline to 72hours

total lymphocyte count

时间窗: from preoperative baseline to 72hours

albumin

时间窗: from preoperative baseline to 72hours

creatinine

时间窗: from preoperative baseline to 72hours

potassium

时间窗: from preoperative baseline to 72hours

troponin-T

时间窗: from preoperative baseline to 72hours

CRP

时间窗: from preoperative baseline to 72hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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