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

NCT ID: NCT07101367

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Systemic Inflammatory Response Syndrome Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group without any medications Dexmedetomidine group Methylprednisolone group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomized Double blinded clinical trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Control group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control group (placebo) Precedex (active comparator) Solumedrol (active comparator)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Assem Abourawash, Masters

Role: CONTACT

00201064013278

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MD219/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.