Effect of topical Desmopressin on bleeding and quality of surgical field during Functional Endoscopic Sinus Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the effects of topical Desmopressin as a premedication, on intraoperative bleeding and quality of surgical field during FESS.
研究概览
简要总结
Chronic rhinosinusitis is a long term inflammatory condition that affects the mucosa of the nose and paranasal sinuses chronic rhinosinusitis can be associated with nasal polyposis or without nasal polyposis If patient does not respond well to the maximum drug treatment and having nasal polys functional endoscopic sinus surgery FESS will be the treatment of choice FUNCTIONAL ENDOSCOPIC SINUS SURGERY is a non invasive or minimally invasive surgical procedure which restores the paranasal sinus function it re establishes physiological pattern of ventilation and mucociliary clearance Multiple techniques are already in use to improve surgical field by reducing blood loss like hypotensive anesthesia GA bipolar diathermy topical vasoconstrictors local injection of epinephrine reverse Trendelenburg position None of them permanently provide an ideal surgical field Bleeding in FESS remains a challenge for surgeons and anesthesiologists Desmopressin is 1-deamino-8-D-arginine vasopressin is a synthetic peptide and selective V2 agonist synthetic analogue of the antidiuretic hormone L-arginine vasopressin it affects hemostasis through increasing plasma concentrations of tissue plasminogen activator and endothelial factor VIII von willebrands factor thus improving platelet adhesiveness exerting a probable effect on vascular stability Recently hemostatic effects of desmopressin have been considered by surgeon Unique feature of desmopressin its abilitity to create a localized effect focusing its action specifically at the site of bleeding without affecting the systemic hemostasis is utilized in this study So this study is conducted to evaluate the effect of intranasal desmopressin spray as a premedication before functional endoscopic sinus surgery as a noninvasive technique and with minimal adverse effects to improve quality of surgical field
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Candidates of FESS due to chronic rhinosinusitis(with & without polyposis) Candidates with chronic rhinosinusitis with no response to medical therapy Candidates with normal preoperative serum and urine sodium levels Candidates with normal coagulation profile.
排除标准
- •Revision FESS Coagulopathies, bleeding disorders Candidates on anticoagulants, vitamin E, diuretics , herbal medicines Known allergy to desmopressin Uncontrolled hypertension,cerebrovascular disease, significant coronary artery diseases or arrythmias Compromised renal and hepatic function Hyponatremia Diabetes , seizure disorders Sinonasal tumors Pregnancy.
结局指标
主要结局
To evaluate the effects of topical Desmopressin as a premedication, on intraoperative bleeding and quality of surgical field during FESS.
时间窗: Every 15 minutes intraoperatively till the end of surgery.
次要结局
- To assess the effect of topical Desmopressin on hemodynamic parameters.(Every 15 minutes intraoperatively till the end of surgery.)
研究者
Dr. V .Srinivasa
Vinayaka Missions University : Vinayaka Missions Research Foundation (Deemed To Be University)
