Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-12-31

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

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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

Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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dexmedetomedine

The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )

esmolol

Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).

Group Type ACTIVE_COMPARATOR

Esmolol Hydrochloride

Intervention Type DRUG

Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )

Interventions

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Esmolol Hydrochloride

Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )

Intervention Type DRUG

Dexmedetomidine

The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )

Intervention Type DRUG

Other Intervention Names

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esmolol precedex

Eligibility Criteria

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Inclusion Criteria

Patients aging 20-50 years ASA physical status I-II . Males , females

Exclusion Criteria

1. hypertensive patient
2. Patients receiving sedatives as midazolam.
3. Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
4. Patients with cerebrovascular diseases.
5. Patients with impaired kidney function.
6. Patients with history of chronic liver diseases.
7. Patients with asthma, chronic obstructive lung diseases.
8. Patients with diabetes mellitus, coagulation disorders, pregnancy.
9. Patients with history of allergy to the drugs used in the study or patients with substance abuse .

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No