跳至主要内容
临床试验/CTRI/2020/09/027652
CTRI/2020/09/027652尚未招募不适用

Comparison of local and systemic effects of different concentrations of adrenaline nasal packs in endoscopic sinus surgery

GMCH1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Extent of adrenaline absorbed into systemic circulation after nasal packing with adrenaline soaked pledgets

研究概览

简要总结

Endoscopicsinus surgery is the surgical procedure used in the management of chronic rhinosinusitis,benign nasal tumours as well as selected malignant nasal tumours as well as indiseases of the orbit. One of the challenges in endoscopic sinus surgery is propervisualization of anatomical landmarks and structures, due to the highvascularity of nose and paranasal sinuses. In addition to this, generalanaesthesia causes an overall vasodilatory effect in the body, leading to ahyperaemic nasal mucosa. Adrenaline used either topically or by infiltration,to achieve hemostasis, has become popular as it is inexpensive and easilyavailable in every hospital.Topical adrenaline in concentration of1:1000, is the most commonly used vasoconstrictor for nasal packing currently.It aids in achieving haemostasis and prolonging the duration of action of localanaesthetics when added with them. By acting on both alpha and beta adrenergicreceptors of the body, adrenaline produces effects like increasedvasoconstriction (locally and systemically) and increased heart rate, cardiacoutput and contractility.These physiological effects of adrenaline pose a riskof complications like  hypertension,coronary ischemia, ventricular dysrhythmias and cerebral haemorrhageetc.

The literatureregarding systemic absorption of adrenaline and comparing differentconcentrations of adrenaline and the effects it has on surgical visibility andhemodynamic parameters is very limited. Thus, this study is being done to assess thesystemic absorption of adrenaline present in nasal packs, the haemodynamiceffects caused by it and the improvement in surgical field obtained when twodifferent concentrations of adrenaline are used.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc

入排标准

年龄范围
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing endonasal sinus surgery of age between 10-60 years and of either sex will be included in this study.

排除标准

  • Patients who have already undergone previous endoscopic sinus surgery.
  • Patients with uncontrolled hypertension, coronary artery disease or cerebro- vascular accident.
  • Patients who are younger than 10 years of age or older than 60 years of age Patients operated under local anaesthesia.
  • Patients requiring infiltration of adrenaline.

结局指标

主要结局

Extent of adrenaline absorbed into systemic circulation after nasal packing with adrenaline soaked pledgets

时间窗: measured at 0,4,8 and 15 minutes

次要结局

  • the haemodynamic parameters of the patient, with different concentrations of adrenaline used.(at 0,4,8 and 15 minutes)

研究者

发起方
GMCH
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验

To study the effects of nasal packing with different... | 临床试验