Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- surgical field scale
研究概览
简要总结
Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".
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, Investigator, Outcomes Assessor)
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 Anesthesiologists (ASA) physical status I and II
- •Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy
排除标准
- •Known allergy to study drugs.
- •History of coagulopathy or bleeding disorders.
- •Patients with hypertension or ischemic heart disease.
- •patients on anticoagulants, antiplatelets or NSAIDs
- •history of deep vein thrombosis, stroke or peripheral vascular disease.
研究组 & 干预措施
tranexamic acid
Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.
干预措施: intravenous tranexamic acid (Drug)
phenylephrine
phenylephrine-soaked pack will be applied after induction of surgery and intubation.
干预措施: Topical Phenylephrine Solution (Drug)
结局指标
主要结局
surgical field scale
时间窗: intraoperativel
the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding 1. = Minimal bleeding: Not a surgical nuisance and no suction required 2. = Mild bleeding: Occasional suction required, but does not affect dissection 3. = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4. = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5. = Massive bleeding: Prevent dissection.
次要结局
- Volume of Blood loss(intraoperative)
- Duration of surgery(the duration from induction of anesthesia till extubation)
- Avoidance of postoperative nasal packing(immediately after the surgey)
- Intra-operative and Postoperative complications(intraoperative and 24 hours postoperative)
研究者
Ahmed Aboulfotouh Mohammed
lecturer of Anesthesia and icu
Assiut University