Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

Phase 1

• Conditions: Cognitive Dysfunction
• Interventions: Drug: Dexmedetomidine; Drug: Esmolol Hydrochloride

• Registration Number: NCT03892512
• Lead Sponsor: Beni-Suef University

Brief Summary

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

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

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-23
• Study First Submitted QC: 2019-03-26
• Last Update Submitted: 2019-03-26
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27
• Study Start: 2019-04
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomedine	Dexmedetomidine	The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .
esmolol	Esmolol Hydrochloride	Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).

Primary Outcome Measures

Name	Time	Method
assess the early cognitive dysfunction after controlled hypotensive anesthesia	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.,

Trial Locations

Locations (1)

Beni-Suef University Hospital; 🇪🇬 Banī Suwayf, Egypt