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临床试验/NCT01387568
NCT01387568已完成3 期

The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Lidocaine group

干预措施: Lidocaine Infusion (Drug)

group P

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed R El Tahan

Associate Professor of Anesthesiology

Mansoura University

研究点 (1)

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