Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- duration of analgesic free
研究概览
简要总结
Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •patient who scheduled laparoscopic cholecystectomy under general anesthesia
- •American Society of Anesthesiologist(ASA) class I or II
- •adult patient (age 20 - 65)
排除标准
- •patient who has liver disease
- •patient who has kidney disease
- •patient who has diabetes mellitus(DM) or heart disease
- •patient who takes opioid or beta-blocker
- •patient who has airway disease
- •patient who has allergy with the drug
研究组 & 干预措施
Nefopam
The generic name is 'ACUPAN'. It is infused during operation. A induction dose is 0.3mg/Kg. A maintenance dose is 65 mcg/kg/hr
干预措施: Nefopam (Drug)
Ketamine
It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr
干预措施: Ketamine (Drug)
Saline
It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr
干预措施: Saline (Drug)
结局指标
主要结局
duration of analgesic free
时间窗: During 1 hour at PACU
analgesic requirement
时间窗: During 1 hour at PACU
次要结局
- analgesic requirement(During 8 hours after arriving at ward)
- Pain on the VAS scale(During 1 hour at PACU)
研究者
Lee Mi Hyeon
assistant professor
Hallym University Kangnam Sacred Heart Hospital