Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- bleeding during surgery
研究概览
简要总结
Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.
Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.
详细描述
After obtaining local ethical committee approval and written informed consent from the patients, 90 adult patients of both sex, aged between 18 and 50 years, ASA I-II, scheduled for elective functional endoscopic sinus surgery in Ain Shams University hospitals will be enrolled in this randomized, controlled prospective double blinded study.
Exclusion criteria included; patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.
The surgeon will assess the degree of sinus involvement in each patient using the Lund-Mackay scoring system. All the patients will be instructed to take prednisone 1 mg. kg-1 5 days before surgery to reduce inflammation.
After applying basic monitors, all patients will be premedicated with midazolam 0.05 mg.kg -1 IV, ranitidine 50 mg IV and dexamethasone 10 mg IV, 15 min. prior to surgery.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 2-2.5 mg.kg -1 and atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent endoscopic sinus surgery
排除标准
- •patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.
研究组 & 干预措施
control
干预措施: Tranexamic Acid (Drug)
local group
干预措施: Tranexamic Acid (Drug)
systemic group
干预措施: Tranexamic Acid (Drug)
combined local and systemic
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
bleeding during surgery
时间窗: time of surgery
surgeon satisfaction
次要结局
未报告次要终点
研究者
Ossama Mustafa Mady
Ain Shams University
Ain Shams University