Back to resultsDexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction
Primary Purpose
Cognitive Dysfunction
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Esmolol Hydrochloride
Dexmedetomidine
Sponsored by
About this trial
This is an interventional screening trial for Cognitive Dysfunction
Eligibility Criteria
Inclusion Criteria:
Patients aging 20-50 years ASA physical status I-II . Males , females
Exclusion Criteria:
- hypertensive patient
- Patients receiving sedatives as midazolam.
- Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
- Patients with cerebrovascular diseases.
- Patients with impaired kidney function.
- Patients with history of chronic liver diseases.
- Patients with asthma, chronic obstructive lung diseases.
- Patients with diabetes mellitus, coagulation disorders, pregnancy.
- Patients with history of allergy to the drugs used in the study or patients with substance abuse .
Sites / Locations
- Beni-Suef University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dexmedetomedine
esmolol
Arm Description
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).
Outcomes
Primary Outcome Measures
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.,
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03892512
Brief Title
Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomedine
Arm Type
Active Comparator
Arm Description
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .
Arm Title
esmolol
Arm Type
Active Comparator
Arm Description
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).
Intervention Type
Drug
Intervention Name(s)
Esmolol Hydrochloride
Other Intervention Name(s)
esmolol
Intervention Description
Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )
Primary Outcome Measure Information:
Title
assess the early cognitive dysfunction after controlled hypotensive anesthesia
Description
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.,
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aging 20-50 years ASA physical status I-II . Males , females
Exclusion Criteria:
hypertensive patient
Patients receiving sedatives as midazolam.
Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
Patients with cerebrovascular diseases.
Patients with impaired kidney function.
Patients with history of chronic liver diseases.
Patients with asthma, chronic obstructive lung diseases.
Patients with diabetes mellitus, coagulation disorders, pregnancy.
Patients with history of allergy to the drugs used in the study or patients with substance abuse .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samaa ak Rashwan, MD
Phone
020120159125
Email
samakassemrashwan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samaa ak Rashwan, MD
Organizational Affiliation
Assisstant proffesor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-Suef University Hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samaa Rashwan, MD
Phone
0201270159125
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction
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