Comparative Effect of Hypotensive Anaesthesia Using Nitroglycerine vs Phentolamine on Event Related Potentials, Quantitative Electroencephalograghy and Cognitive Function in Patients Undergoing Septoplasty
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Paired Associate Learning test for assessment of Cognitive function
研究概览
简要总结
AIM OF THE WORK The aim of this work was to compare the effect of hypotensive anaesthesia using Nitroglycerine versus phentolamine on Event related potentials, quantitative Electroencephalograghy and cognitive function, in patients undergoing septoplasty.
详细描述
METHODS:
Study design and population: This is a pilot prospective randomized clinical trial that will be carried out on 60 patients candidate for septoplasty subjected to general hypotensive anaesthesia. The patients will be recruited from Ear, nose and throat surgery department, Beni-Suef University Hospital. All the participants will be required to offer a written informed consent
Sampling Technique:
Patients will be randomly assigned into one of two equal groups; the first group will receive nitroglycerine (30 participants) (nitroglycerine group) and the second group will receive phentolamine (30 participants) (phentolamine group). Randomization will be carried out using a closed opaque envelope technique with the anesthetist will pick up a sealed envelope which contains a paper with the name of the group to which the patient will be randomized is written. Whichever the group written on the paper, the patient will be scheduled to it.
All included patients will be subjected to the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are candidate for septoplasty
- •Patients from both sexes, aged between 20-50 years
排除标准
- •Patients who develop intraoperative shock or major bleeding
- •Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases, or uncontrolled hypertension
- •Patients with a history of central neurological system disorder
- •Patients with concomitant medical or metabolic illness known to affect cognition
- •Pregnant females
- •Allergy to any of the anaesthetic or hypotensive drugs used in the study
研究组 & 干预措施
Nitroglycerine
Patients will receive hypotensive anesthesia with nitroglycerine infusion via syringe pump by adding 5mg (5ml) of Nitroglycerin to 45ml of normal saline making it to final concentration of 100μg/ml at the rate of 0.5- 10 μg/kg/min according to the patients desired target blood pressure.
干预措施: hypotensive anaesthesia using Nitroglycerine (Drug)
Phentolamine
Patients will receive hypotensive anesthesia with phentolamine infusion via syringe pump by adding 20 mg (2ml) of Phentolamine to 48 ml of normal saline making it to final concentration of 0.4 mg/ml at the rate of 0.1-2 mg/min according to the patients desired target blood pressure.
干预措施: hypotensive anaesthesia using Nitroglycerine (Drug)
结局指标
主要结局
Paired Associate Learning test for assessment of Cognitive function
时间窗: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Benton Visual Retention test for assessment of Cognitive function
时间窗: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
次要结局
- Quantitative Electroencephalograghy for assessment of electrical activity of the brain(1 week)
- Event related potentials (ERP ) P300 for neurophysiological assessment of cognition(1 week)
研究者
Mona Hussein
Neurology lecturer
Beni-Suef University