Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03892512

Enrollment

Registered

2019-03-27

Start date

2019-04-30

Completion date

2019-12-31

Last updated

2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

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

Interventions

DRUGEsmolol Hydrochloride

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

DRUGDexmedetomidine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
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.,

Countries

Egypt

Contacts

Primary ContactSamaa ak Rashwan, MD

samakassemrashwan@gmail.com020120159125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026