Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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The Effect of Dexmedetomidine and Esmolol on Early Post Operative Cognitive Dysfunction After Middle Ear Surgery Under Hypotensive Technique :Comparative , Randomized Double Blinded Study

Conditions
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Cognitive Dysfunction

Intervention / Treatment
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* Drug: Esmolol Hydrochloride
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aging 20-50 years ASA physical status I-II . Males , females Exclusion Criteria: 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 .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomedine<br>The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) . | Drug: Dexmedetomidine<br>* The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )<br>* Other names: precedex;|
| Active Comparator: esmolol<br>Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ). | Drug: Esmolol Hydrochloride<br>* Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )<br>* Other names: esmolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the early cognitive dysfunction after controlled hypotensive anesthesia | 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., | 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 |