Coronary Artery Disease, Postoperative Complications, Systemic Inflammatory Response Syndrome
Conditions
Brief summary
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
Interventions
DRUGNormal saline
After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU
DRUGDexmedetomidine
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
DRUGMethylprednisolone
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomized Double blinded clinical trial
Intervention model description
Control group without any medications Dexmedetomidine group Methylprednisolone group
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induced inflammatory response | First 24 hours post cardio-pulmonary bypass | Effect of both drugs on attenuating induced inflammatory response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | First 24 hours post cardio-pulmonary bypass | Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score |
Countries
Egypt
Contacts
Primary ContactAssem Abourawash, Masters
Outcome results
None listed