Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: a Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons to secure the airway and control blood pressure.
详细描述
Bleeding even minor can obscure the surgical field. This can extend the operative time & increase the failure rate. The hemostatic effect of desmopressin on the quality of the surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed that desmopressin could reduce intraoperative bleeding.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-45 years old.
- •Physical status: ASA I & II.
- •Type of operations: elective endonasal dacryocystorhinostomy under general anesthesia.
- •Written informed consent from the patient.
排除标准
- •Patient refusal.
- •Known hypersensitivity to study drugs.
- •Nasal pathology as active infection or an anatomical abnormality.
- •Hyponatremia "serum Na+ less than 135".
- •Coagulation disorders.
- •Renal or cardiovascular disorders.
研究组 & 干预措施
Desmopressin group
The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery "Minirin 10 μg/0.1 ml per spray, Ferring Pharmaceutical Company". Three normal saline-soaked packs will be placed in the middle meatus for 5 minutes immediately before the start of surgery.
干预措施: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: Measurement will be done at 60th minutes of the start of surgery.
Estimation of intraoperative blood loss will be done at 60th minutes of surgery. by calculating the loss of blood and irrigation saline in 50 mL-graded suction canisters.
次要结局
- Change in serum sodium level(preoperative and after 12 hours postoperative)
- Change in heart rate (HR) in beat per minute(will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.)
- The surgeon's satisfaction(At the end of surgery)
- The Surgical field clarity(at the end of surgery)
- Change mean arterial blood pressure (MAP) in mmHg(will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.)
- Change oxygen saturation (SPO2)(will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.)