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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Postoperative Complications; Systemic Inflammatory Response Syndrome
• Interventions: Drug: Normal saline; Drug: Methylprednisolone; Drug: Dexmedetomidine

• Registration Number: NCT07101367
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	Control group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU
Methylprednisolone	Methylprednisolone	To be diluted in 10 ml normal saline then given after induction of anesthesia then followed by normal saline infusion till extubation in ICU
Dexmedetomidine	Dexmedetomidine	Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU

Primary Outcome Measures

Name	Time	Method
Induced inflammatory response	First 24 hours post cardio-pulmonary bypass	Effect of both drugs on attenuating induced inflammatory response

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt