Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Hyperalgesic extent around surgical incision
研究概览
简要总结
Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was reported to occur after surgery when large amount of remifentanil was administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to have analgesic and anti-hyperalgesic effect.
The investigators hypothesized that nefopam administration could prevent OIH or reduce the severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic gastrectomy
- •American Society of Anesthesiologists physical status I or II
- •aged from 20 to 65 years
排除标准
- •Past history of chronic pain
- •Drug or alcohol abuse
- •Psychotic disorder
- •Taking analgesics, anti-epileptics, and anti-depressants.
- •Taking opioids within 24 hrs
- •Renal disease
- •Neuromuscular disease.
- •Moderate to severe cardiovascular disease
- •Pregnant or breast-feeding
研究组 & 干预措施
group L
receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
干预措施: low dose remifentanil (Drug)
group H
100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
干预措施: high dose remifentanil (Drug)
group N
20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
干预措施: Nefopam (Drug)
结局指标
主要结局
Hyperalgesic extent around surgical incision
时间窗: Postoperative 24 hr and 48 hr
The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).
次要结局
未报告次要终点