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临床试验/NCT00242697
NCT00242697已完成3 期

A Randomized Double-Blind Comparison of Combined General-Spinal Anesthesia to General Anesthesia for Coronary Artery Surgery

University of Calgary2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2002年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
63
试验地点
2
主要终点
analgesic requirement in the intensive care unit

研究概览

简要总结

Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia. This study subjected these techniques to a double-blind randomized trial.

详细描述

Use of neuraxial agents in anesthesia for cardiac surgery is expanding. We have used combined general-spinal anesthesia for cardiac surgery for 12 years. We performed a trial in order to determine if our clinical impressions of the techniques would be confirmed. We hypothesized that compared to general anesthesia, the combined techniques would provide comparable intraoperative hemodynamics and improved postoperative analgesia. This study subjected these techniques to a double-blind randomized trial.

METHODS

After IRB approval, 63 consenting patients undergoing non-emergent coronary artery bypass grafting (CABG) entered a randomized, double-blind trial. Patients received lorazepam 0.03 mg/kg preoperatively, and midazolam 0.03 mg/kg during line insertion and induction. Spinal procedures, performed by an unblinded study anesthesiologist, preceded general anesthesia, which was induced with propofol and rocuronium, and maintained with isoflurane through CPB, and propofol thereafter. All caregivers were blinded to group assignment. Opioid and spinal management defined 3 groups:

GA: Sufentanil IV: 3 μg/kg induction, 1 μg/kg x 2 prn; mock spinal SO: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 50 μg, morphine 0.5 mg, hyperbaric SL: Sufentanil IV: 0.2 μg/kg induction, 0.1 μg/kg x 2 prn; Spinal: sufentanil 25 μg, morphine 0.5 mg, bupivacaine 9.75 mg, hyperbaric

When patients were stable in ICU, propofol was stopped and an extubation protocol begun. Patients received scheduled NSAID and prn opioid, IV or PO. The chi-square test and ANOVA using the Scheffe method for multiple comparisons were applied appropriately.

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
Double

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing non-emergent primary coronary artery bypass grafting using cardiopulmonary bypass

排除标准

  • < 25 or > 80 years of age
  • left ventricular ejection fraction < 35%
  • receiving inotropic or intraaortic balloon therapy at time of surgery
  • receiving intravenous heparin therapy at time of surgery
  • pre-existing back problems in the lumbar area
  • clinical or laboratory evidence of coagulopathy

结局指标

主要结局

analgesic requirement in the intensive care unit

visual analogue pain scores in the intensive care unit

duration of endotracheal intubation in the intensive care unit

次要结局

  • intraoperative hemodynamic variables
  • intraoperative blood catecholamine and lactate levels
  • intraoperative anesthetic supplementation
  • intraoperative vasoactive drug therapy

研究者

申办方类型
Other

研究点 (2)

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