Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups
研究概览
简要总结
Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.
详细描述
45 patients undergoing total laryngectomy operation will be enrolled in this study. The patients will be divided into 3 equal groups, 15 patients in each group. Group (A), tranexamic acid will be given 1 hr preoperatively. Group (B), topical tranexamic acid will be given as an irrigation to the surgical site. Group (C), control group.One hour preoperatively, a wide bore cannula will be inserted to all patients. Tranexamic acid 1mg/kg will be given intravenously to patients in group (A). Normal saline will be given to Group (B) and group (C) .On arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ECG), and non-invasive blood pressure measurement device will be connected to the patient. Pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. Induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. After intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg Morphine sulphate . Anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. After flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (B), and by normal saline in group (A) and group (C).
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
All procedures will be performed by the same team, all of whom will be blind to the group assignment (except for the resident who will prepare the drug formula whether intravenous or the topical irrigation and will be responsible for randomization and drug masking using closed envelope randomization)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.
研究组 & 干预措施
Group (A), tranexamic acid IV
tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously
干预措施: Tranexamic acid (Drug)
Group (B), topical tranexamic acid
topical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours .
干预措施: Tranexamic acid (Drug)
Group (C), control group.
Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups
时间窗: Intraoperative
Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges)
次要结局
未报告次要终点
研究者
Dina Mahmoud Mohamed
Lecturer of Anesthesia and Surgical ICU and pain management
Kasr El Aini Hospital