Lidocaine Infusion in Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
详细描述
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).
Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, 20-50 yr ASA class I and II
- •Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
排除标准
- •Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index > 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
研究组 & 干预措施
Lidocaine
IV Lidocaine infusion
干预措施: Lidocaine (Drug)
Control
IV normal saline infusion
干预措施: Normal saline (Drug)
结局指标
主要结局
Intraoperative bleeding
时间窗: Intraoperative assessment till end of operation
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
次要结局
- Surgeon satisfaction(At the end of surgery)
- Heart rate(intraoperative assessment)
- Mean arterial pressure(intraoperative assessment)
- Quality of surgical field(intraoperative assessment)
研究者
Seham Mohamed Moeen Ibrahim
lecturer
Assiut University