The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Intraoperative field bleeding
研究概览
简要总结
The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.
详细描述
The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.
Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists grade I or II.
- •Sex: Both sexes.
- •Age between 18 and 40 years.
- •Patients scheduled for FESS under general anesthesia.
排除标准
- •Declining to give written informed consent.
- •History of allergy to the medications used in the study.
- •History of venous or arterial thrombosis.
- •history of cardiovascular diseases including AF, IHD, or hypertension.
- •History of chest problems including pulmonary embolism, bronchial asthma and COPD.
- •History of cerebrovascular stroke.
- •History of drug or alcohol abuse.
- •Taking opioids or sedative medications.
- •Hepatic or renal failure.
- •Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
研究组 & 干预措施
Oral tranexamic
The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
干预措施: Oral tranexamic acid (Drug)
Intravenous tranexamic
The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.
干预措施: Intravenous tranexamic acid (Drug)
结局指标
主要结局
Intraoperative field bleeding
时间窗: At 30 minutes after surgery start
The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills \< 10 seconds)
次要结局
- Incidence of the common adverse effects(At 24 hours)
- Post operative D-dimer(At 24 hours)
研究者
Tamer Samir Abdelsalam
Lecturer of Anesthesia
Ain Shams University