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NCT Number: NCT07101367

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shock Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain Shams University

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 21-60 years.
  • Sex: Both sexes.
  • American Society of Anaesthesiologists (ASA) Physical Status Class II, and III.
  • Scheduled for CABG on cardio-pulmonary bypass.

Exclusion criteria

  • Declining to give a written informed consent.
  • History of allergy to the medications used in the study.
  • Psychiatric disorders.
  • Significant cognitive dysfunction.
  • American Society of Anesthesiologists (ASA) Physical Status Class IV.
  • Chronic liver or kidney disease.
  • Poor systolic function ( Ejection fraction < 40% ).
  • Pregnancy.
  • 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.

Treatment and study plan

normal saline

Drug

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)

Dexmedetomidine

Drug

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)

methylprednisolone

Drug

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)

Primary outcomes

  1. Induced inflammatory response

    Time frame: First 24 hours post cardio-pulmonary bypass

    Effect of both drugs on attenuating induced inflammatory response

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Assem Abourawash, Masters

CONTACT

[email protected]

00201064013278

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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