Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass
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
- 否
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
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
