Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Peripheral perfusion index
研究概览
简要总结
Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension
详细描述
Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Adult male or female patients
- •18-45 years
- •ASA physical status I-II
- •scheduled for FESS operations
排除标准
- •uncontrolled hypertension
- •cerebrovascular disorders
- •coagulation disorders
- •cardiovascular diseases
- •renal impairment
- •liver impairment
- •history of allergic reaction to any of the study medications
研究组 & 干预措施
group N
Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
干预措施: Nitroglycerin (Drug)
group L
Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
干预措施: Labetalol (Drug)
结局指标
主要结局
Peripheral perfusion index
时间窗: 4 hours
Peripheral perfusion index will be used as a marker of peripheral perfusion.
次要结局
- Heart rate(4 hours)
- Total blood loss(from beginning of surgery till the end of the procedure)
- Mean arterial blood pressure(4 hours)
- Change in serum lactate concentration(Immediately before induction of anesthesia and after 60 minutes post recovery.)
- Surgical field score (SFS)(from beginning of surgery till the end of the procedure.)
研究者
Heba Nassar,MD
Associate professor of Anesthesia
Cairo University
