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

August 1, 2025 updated by: Ain Shams University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU
Drug: Normal saline
After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU
Other Names:
  • Control group (placebo)
Active Comparator: Dexmedetomidine
Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU
Drug: Dexmedetomidine
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
Other Names:
  • Precedex (active comparator)
Active Comparator: 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
Drug: Methylprednisolone
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
Other Names:
  • Solumedrol (active comparator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induced inflammatory response
Time Frame: First 24 hours post cardio-pulmonary bypass
Effect of both drugs on attenuating induced inflammatory response
First 24 hours post cardio-pulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: First 24 hours post cardio-pulmonary bypass
Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score
First 24 hours post cardio-pulmonary bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 24, 2025

First Submitted That Met QC Criteria

July 31, 2025

First Posted (Actual)

August 3, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD219/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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