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

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

Study Overview

• Status: Unknown
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Esmolol Hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Beni-Suef University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dexmedetomedine; The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .	Drug: Dexmedetomidine; The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex ); Other Names: precedex
ACTIVE_COMPARATOR: esmolol; Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).	Drug: Esmolol Hydrochloride; Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride ); Other Names: esmolol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: March 23, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Adrenergic beta-1 Receptor Antagonists; Dexmedetomidine; Esmolol
• Other Study ID Numbers: Beni-Suef

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No