The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.
详细描述
The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.
Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric
- •Abdominal surgery
- •ASA class I and II
排除标准
- •history of hepatic diseases
- •history of cardiac diseases
- •history of renal diseases
- •allergy to local anesthetics
研究组 & 干预措施
group L
Lidocaine group
干预措施: Lidocaine Infusion (Drug)
group P
Placebo group
干预措施: saline Infusion (Drug)
结局指标
主要结局
Blood pressure
时间窗: for 2hrs after infusion
次要结局
- Plasma Cortisol(for 24 hrs after infusion)
- Serum lidocaine(6 hrs after infusion)
- Heart rate (HR)(for 6 hrs after infusion)
- Pain scales(24 hrs postoperative)
研究者
Mohamed R El Tahan
Associate Professor of Anesthesiology
Mansoura University
