comparison of intranasal and intravenous dexmedetomidine infusion in providing induced hypotension in functional endoscopic sinus surgery(FESS)-A Randomised double blind trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the Target MAP to achieve bloodless field in the two group of
研究概览
简要总结
Functional endoscopic sinus surgery is a minimally invasive procedure and considered
to be the primary approach used today for the surgical treatment of chronic sinusitis and
sinonasal polyps that is commonly performed under controlled hypotensive anesthesia. In
FESS surgeries,due to excessive bleeding which leads to impaired visibility of the operative
field and various complications. So a dry operative field is necessary for a more definitive
removal of the polyp (lesion) ,so the vital structures less damaged and thereby tissue
infection is also minimized. Controlled hypotension is a technique used to limit
intraoperative blood loss and provide the best possible field for surgery.
Induced or Controlled hypotension is a technique in which the arterial blood pressure is
decreased in a predictable and deliberate manner. The intent of deliberate hypotension is to
reduce bleeding that facilitate surgery and to decrease the need for blood transfusion
The target of induced hypotension is (60-70mmhg), Hypotension is defined as MAP
<55mmHg.Several drugs have been used successfully to produce controlled hypotension IN
FESS during general anesthesia for example inhalational anesthetics, direct vasodilators
(sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol 2 and
esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel
blockers, prostaglandin E1 (alprostadil), adenosine[1] and l-receptors agonists
(remifentanil).
IV Dexmeditomedine infusion has been studied in various surgery in producing
controlled hypotension The newer α2-adrenergic agonist Dexmedetomidine was introduced
in the market in 1999 for sedating patients on mechanical ventilation those who are
admitted in intensive care units, Later it was approved by FDA for ICU
sedation.Dexmedetomidine is an α2-2 adrenergic receptor agonist with sedative, anxiolytic,
sympatholytic, and devoid of respiratory depression and analgesic effects best described as
opiod sparing,Dexmeditomedine is rapid in onset and short acting,though intravenous
dexmeditomedine infusion has been studied extensively in doses ranging from 0.4-
0.6mcg/kg in FESS surgery Previous studies have reported that intranasal DEX 1–
1.5mcg/kg produced significant sedation within 45–60 min and its elimination half-life was
114 min in healthy volunteers.
Though Intranasal DEXMED Dose range to 1 to 3mcg/kg in paediatrics has been
studied for premedicaton in paediatrics as,well as in adults including elderly in reducing
agitation,pain and haemodynamic stability,,its use in FESS surgery not being studied.hence
we would like to compare efficacy of intranasal dexmed versus intravenous dexmed
infusion in providing induced hypotension analgesic and bloodless surgical field in FESS
surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients belonging to ASA 1 and ASA 2 physical status, surgery duration of less than 3hours.
排除标准
- 未提供
结局指标
主要结局
To compare the Target MAP to achieve bloodless field in the two group of
时间窗: At baseline,5mins,10mins,15mins,30mins, | 1hours,1:30hours,2hours,2:30hours,3hours and postoperatively 30min,1hour,1:30hour,2hours
patients(IV &IN Dexmedotimine group)
时间窗: At baseline,5mins,10mins,15mins,30mins, | 1hours,1:30hours,2hours,2:30hours,3hours and postoperatively 30min,1hour,1:30hour,2hours
次要结局
未报告次要终点
研究者
DR RAM PANDIAN G
Sri Balaji vidyapeeth university
