The Effect of Dexmedetomidine and Esmolol on Early Post Operative Cognitive Dysfunction After Middle Ear Surgery Under Hypotensive Technique :Comparative , Randomized Double Blinded Study
试验速览
- 阶段
- 1 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- assess the early cognitive dysfunction after controlled hypotensive anesthesia
研究概览
简要总结
Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression.
From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine.
Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages
详细描述
The study will be a randomized double blinded study and will be carried by the Department of Anaesthesia at Beni-Suef University Hospital after obtaining approval from local research and ethical committee. Written informed consent will be obtained from each patient before operation. Aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aging 20-50 years ASA physical status I-II . Males , females
排除标准
- •hypertensive patient
- •Patients receiving sedatives as midazolam.
- •Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
- •Patients with cerebrovascular diseases.
- •Patients with impaired kidney function.
- •Patients with history of chronic liver diseases.
- •Patients with asthma, chronic obstructive lung diseases.
- •Patients with diabetes mellitus, coagulation disorders, pregnancy.
- •Patients with history of allergy to the drugs used in the study or patients with substance abuse .
研究组 & 干预措施
dexmedetomedine
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .
干预措施: Dexmedetomidine (Drug)
esmolol
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).
干预措施: Esmolol Hydrochloride (Drug)
结局指标
主要结局
assess the early cognitive dysfunction after controlled hypotensive anesthesia
时间窗: MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen
mini mental state examination (MMSE) will be used for evaluation of cognitive function Data will be expressed in mean ± SD and were compared using analysis of variance (ANOVA). The significance of non-parametric data was determined using chi-square test. For all comparisons P \< 0.05 was considered significant.,
次要结局
未报告次要终点
研究者
Samaa Rashwan
Samaa Abou Alkassem Rashwan
Beni-Suef University