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临床试验/NCT01384175
NCT01384175已完成不适用

Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting

Northern State Medical University2 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
2
主要终点
Duration of postoperative mechanical ventilation

研究概览

简要总结

The aim of the present study was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion and patient-controlled epidural analgesia with ropivacaine/fentanyl in off-pump coronary artery bypass grafting

详细描述

Ninety-three patients were scheduled for off-pump coronary artery bypass (OPCAB) under propofol/fentanyl anesthesia. Day before surgery patients were asked for informed consent and randomized into three postoperative analgesia regimens aiming at a visual analog scale (VAS) score <30 mm at rest. The control group (n=31) received intravenous fentanyl 10 µg/ml postoperatively 3-8 mL/h. After placement of an epidural catheter at the level of Th2-Th4 before OPCAB, a thoracic epidural infusion (EI) group (n=31) received epidural anesthesia (EA) intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous EI of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. The patient-controlled epidural analgesia (PCEA) group (n=31), in addition to EA and EI, received PCEA (ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min) postoperatively. Hemodynamics and blood gases were measured throughout 24 h after OPCAB.

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
None

入排标准

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

入选标准

  • presence of coronary artery disease
  • ASA II-III
  • elective off-pump coronary artery bypass

排除标准

  • age < 18 years
  • severe valve dysfunction or peripheral vascular disease
  • simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
  • transfer to CPB during surgery

研究组 & 干预措施

intravenous analgesia

Active Comparator

Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.

干预措施: intravenous analgesia (Procedure)

epiduaral infusion

Active Comparator

Patients received epidural analgesia intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively.

干预措施: epidural infusion (Procedure)

patient-controlled epidural analgesia

Active Comparator

In addition to epidural anesthesia and epidural infusion, postoperatively patients received patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min.

干预措施: patient-controlled epidural analgesia (Procedure)

结局指标

主要结局

Duration of postoperative mechanical ventilation

时间窗: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours

Duration of postoperative mechanical ventilation, hours

次要结局

  • Hemodynamic stability(All period of operation and during 24 hours postoperatively)

研究者

发起方
Northern State Medical University
申办方类型
Other

研究点 (2)

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