The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The variation of Interleukin-6 levels
研究概览
简要总结
Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).
For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.
For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.
Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.
详细描述
Patients undergoing open colorectal surgery with tumor resection were randomised prospectively into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).
For the IV-Lido group (n=25), patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 1.5 mg/kg/h over twenty-four hours.
For the IV-Keta goup(n=25), patients received a loading dose of 0.15mg/kg of Ketamine than a continuous injection of 0.15 mg/kg/h of Ketamine over twenty-four hours.
For both groups, plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. Plasma IL-6 concentrations at each point were compared between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IV-Lido
Intravenous Lidocaine dose loading than continuous infusion
干预措施: Lidocaine IV (Drug)
IV-Keta
Intravenous Ketamine dose loading than continuous infusion
干预措施: Ketamine Injectable Solution (Drug)
结局指标
主要结局
The variation of Interleukin-6 levels
时间窗: 24 hours after surgery
The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.
次要结局
- Bowel function.(During the first 24 hours postoperatively)
- Pain assessed by Numerical Rating Scale (NRS)(Postoperatively, at Hour 2, Hour 12 and Hour 24. the patient asked to circle the number between 0 and 10:"0" usually represents 'no pain at all' whereas "10" represents 'the worst pain ever possible'.)
- Post-operative nausea and vomiting(During the first 24 hours postoperatively)
- Hospital length of stay.(From date of randomization until the date of to discharge from the hospital assessed up to 15 days)
- Post-operative complications.(From date of randomization until the date of to discharge from the hospital assessed up to 15 days)
研究者
HibetAllah Ktata
Associate Professor
University Tunis El Manar