Effect of Intravenous Infusion of Lidocaine in Comparison to Intravenous Infusion of Dexmedetomidine on Proinflammatory Cytokines and Stress Response in Pelviabdominal Cancer Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- change in serum level of insulin and lactate
研究概览
简要总结
This study is designed to compare between intravenous infusion of dexmedetomidine and intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic requirements in patients undergoing surgery for pelviabdominal cancers.
详细描述
Cancer patients who undergo surgery face many sources of stress. Surgery causes major cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid hormones and other metabolic consequences .This stress response is considered a defense mechanism important for developing resistance to noxious insults.
The cytokine cascade caused by surgical stimulation is complex with various effects on the injured host. Increased production of proinflammatory cytokines from the site of injury causes many systemic changes such as metabolic derangements and hemodynamic instability. Some released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission through cytokine induced release of some neuroactive substances like nitric oxide, oxygen free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are also released during inflammation to counteract these effects and keep balance.
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative, analgesic, anesthetic-sparing properties with no respiratory depression. Its anti-inflammatory effects are being studied.
Intravenous lidocaine can be used in management of chronic pain. Lidocaine has anti-inflammatory properties and is capable of reducing postoperative analgesic requirements and the length of hospitalization.
The effect of both drugs on proinflammatory cytokines and stress response will be assessed
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesia (ASA) Physical Status classification:
- •ASA II physical status.
- •Age between 18 to 60 years old.
- •Patients who will undergo major pelviabdominal surgery.
排除标准
- •Patient refusal.
- •Allergy to local anesthetics.
- •Cognitive disorders.
- •uncontrolled diabetes or hypertension.
研究组 & 干预措施
dexmedetomidine
dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively
干预措施: dexmedetomidine infusion (Drug)
lidocaine
Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively
干预措施: lidocaine infusion (Drug)
placebo
saline infusion will be administered preoperatively and continued intraoperatively
干预措施: Placebos (Drug)
结局指标
主要结局
change in serum level of insulin and lactate
时间窗: preoperative (baseline), immediately postoperative and 24 hours postoperative
change in serum levels of insulin (ng/ml) and lactate (ng/ml)
change in inflammatory mediators
时间窗: preoperative (baseline), immediately postoperative and 24 hours postoperative
change in plasma levels of IL-6 (pg/ml), TNF-α (pg/ml)
次要结局
- Visual analogue scale (VAS) score for pain(at 0 hour, 2 hour,6 hour, 12 hour and 24 hour)
- postoperative morphine requirements(1st 24 hours)
- Rescue analgesia(1st 24 hours)
研究者
Norma Osama Abdalla Zayed
Assistant lecturer of anesthesia
National Cancer Institute, Egypt