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临床试验/NCT01022736
NCT01022736已完成4 期

Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass

Queen's University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
16
试验地点
1
主要终点
plasma concentrations of gabapentin

研究概览

简要总结

This open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • scheduled for cardiac bypass surgery involving median sternotomy and CPB
  • signed informed consent

排除标准

  • history of chronic pain
  • regular opioid consumption
  • regular anticonvulsant consumption
  • regular gabapentin or pregabalin use
  • recent congestive heart failure
  • ejection fraction <35%
  • chronic pulmonary disease
  • liver disease
  • renal insufficiency (preoperative creatinine > 140umol/L
  • history of adverse reaction to acetaminophen

研究组 & 干预措施

gabapentin

Experimental

patients scheduled for cardiac bypass surgery will be administered gabapentin (600mg, orally). Blood will be drawn and plasma gabapentin levels determined 1 hour before surgery, 10 minutes into surgery, 10 minutes before separation from bypass, 30 minutes following bypass, and then before and 2 hours after each dose of gabapentin.

干预措施: Gabapentin (Drug)

结局指标

主要结局

plasma concentrations of gabapentin

时间窗: 1 hour before surgery, 10 min following initiation of bypass, 10 min before separation from bypass, 30 min following bypass, and then before and 2 hours following each of the next 3 doses of gabapentin

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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