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

NCT07101367 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FMASU MD219/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Systemic Inflammatory Response Syndrome; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Induced inflammatory response

  Effect of both drugs on attenuating induced inflammatory response

  First 24 hours post cardio-pulmonary bypass

Secondary Outcomes (1)

• Cognitive function

  First 24 hours post cardio-pulmonary bypass

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Dexmedetomidine

ACTIVE COMPARATOR

Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU

Drug: Dexmedetomidine

Methylprednisolone

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Control group (placebo)

Control

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

Also known as: Precedex (active comparator)

Dexmedetomidine

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

Also known as: Solumedrol (active comparator)

Methylprednisolone

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Infection during the week preceding surgery white blood cell count over 11,000 mm3 10.Pre-operative use of antibiotics or corticosteroids.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease; Systemic Inflammatory Response Syndrome; Postoperative Complications

Interventions

Saline Solution; Control Groups; Dexmedetomidine; Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Assem Abourawash, Masters

CONTACT

00201064013278; assemahmed999@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized Double blinded clinical trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group without any medications Dexmedetomidine group Methylprednisolone group

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2024-08

Locations

EG (1)