Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plasmatic concentration of lidocaine
研究概览
简要总结
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.
Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.
Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.
Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.
Investigators get approbation of local ethic committee for this work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy
- •Body mass index > = 40 kg/m2
- •Informed consent signed
- •Patient treated with intravenous administration of lidocaine
排除标准
- •Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria)
- •Concomitant use of beta blocker and others anti arrhythmic drugs
- •Cardiac or hepatic insufficiency
- •Pregnancy
研究组 & 干预措施
assessment of plasmatic lidocaine rate
Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine
干预措施: Blood sampling (Biological)
assessment of plasmatic lidocaine rate
Patients will receive intravenous administration of lidocaine based on a modified body weight ; blood sampling will be performed to assess plasmatic concentration of lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Plasmatic concentration of lidocaine
时间窗: From bolus to day 1 after cessation of administration
Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period. First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration.
次要结局
- occurence of adverse events related to lidocaine use(Up to 2 days after surgery)