A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG

Ain Shams University60 enrolled

Overview

A comparison between precedex versus solumedrol as anti-inflammatory stress response inhibitors in patients undergoing on-pump CABG using different inflammatroy response parameters and the outcome of the drugs on the cognitive and cardiac status post extubation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Coronary Artery Disease Systemic Inflammatory Response Syndrome Postoperative Complications

Interventions

Normal salineDRUG

After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU

DexmedetomidineDRUG

After induction of anesthesia give loading dose of precedex 1 mcg/kg diluted in 10 ml normal saline then attach syringe pump of precedex infusion of 0.5mcg/kg/hr till extubation in ICU

MethylprednisoloneDRUG

After induction of anesthesia give solumedrol of a dose 10mg/kg diluted in 10ml of normal saline followed by a normal saline infusion till the extubation of the patient in the ICU

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21-60 years. 2. Sex: Both sexes. 3. American Society of Anaesthesiologists (ASA) Physical Status Class II, and III. 4. Scheduled for CABG on cardio-pulmonary bypass. Exclusion Criteria: 1. Declining to give a written informed consent. 2. History of allergy to the medications used in the study. 3. Psychiatric disorders. 4. Significant cognitive dysfunction. 5. American Society of Anesthesiologists (ASA) Physical Status Class IV. 6. Chronic liver or kidney disease. 7. Poor systolic function ( Ejection fraction \< 40% ). 8. Pregnancy. 9. Redo CABG. 9.Infection during the week preceding surgery white blood cell count over 11,000 mm3 10.Pre-operative use of antibiotics or corticosteroids.

Locations (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Induced inflammatory response

Effect of both drugs on attenuating induced inflammatory response

Time frame: First 24 hours post cardio-pulmonary bypass

Secondary Outcomes

Cognitive function

Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score

Time frame: First 24 hours post cardio-pulmonary bypass

Central Contacts

Assem Abourawash, Masters

CONTACT

00201064013278 assemahmed999@gmail.com

Data from ClinicalTrials.gov

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