Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892512
• Other study ID #: Beni-Suef
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Beni-Suef University
• Contact: Samaa ak Rashwan, MD
• Phone: 020120159125
• Email: samakassemrashwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

Drug:
• Esmolol Hydrochloride
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )
• Dexmedetomidine
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )

Locations

Country	Name	City	State
Egypt	Beni-Suef University Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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