Department of Anestheia and Intensive Care Unit,Cairo University
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- perfusion index
研究概览
简要总结
Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.
详细描述
The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 是
入选标准
- •ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)
排除标准
- •uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.
研究组 & 干预措施
nitroglycerin group
this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level
干预措施: Massimo device (Combination Product)
nitroglycerin group
this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level
干预措施: Nitroglycerin drug (Drug)
labetalol group
this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level
干预措施: Massimo device (Combination Product)
labetalol group
this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level
干预措施: Labetalol (Drug)
结局指标
主要结局
perfusion index
时间窗: 3hrs
perfusion index is an indication of peripheral perfusion
serum lactate level
时间窗: 3hrs
lactate level is an indication of central perfusion
次要结局
- surgical feild score(3hrs)
研究者
Amany Hassan Saleh
department of anesthesia and intensive care unit,Cairo university
Cairo University