Coronary Artery DiseasePhase 1/2NCT07101367
A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG
A Phase 1/2 study testing Normal saline, Dexmedetomidine and Methylprednisolone in people with Coronary Artery Disease and Systemic Inflammatory Response Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Systemic Inflammatory Response Syndrome, Postoperative Complications
- What is being tested?
- Normal saline, Dexmedetomidine and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Normal saline, Dexmedetomidine, Methylprednisolone
- Medical subject headings
- Coronary Artery Disease, Systemic Inflammatory Response Syndrome, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called Control group (placebo)
After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU
DexmedetomidineDrug
Also called Precedex (active comparator)
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 called Solumedrol (active comparator)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Normal saline |
| Dexmedetomidine | Active comparator | Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU Receives: 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 Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induced inflammatory response
Effect of both drugs on attenuating induced inflammatory response
Measured: First 24 hours post cardio-pulmonary bypass
Secondary outcomes (1)
Cognitive function
Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score
Measured: First 24 hours post cardio-pulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group without any medications Dexmedetomidine group Methylprednisolone group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101367
- Sponsor's protocol ID
- FMASU MD219/2023
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG
- ClinicalTrials.gov ID
- NCT07101367
- Acronym / sponsor ID
- FMASU MD219/2023
- Conditions
- Coronary Artery Disease, Systemic Inflammatory Response Syndrome, Postoperative Complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Control group without any medications Dexmedetomidine group Methylprednisolone group
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Normal salineControl group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineStarting with precedex loading dose after anesthesia induction then infusion till extubation in ICU |
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneTo be diluted in 10 ml normal saline then given after induction of anesthesia then followed by normal saline infusion till extubation in ICU |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineAlso: Control group (placebo)After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU | Drug | Control |
| DexmedetomidineAlso: Precedex (active comparator)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 | Drug | Dexmedetomidine |
| MethylprednisoloneAlso: Solumedrol (active comparator)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 | Drug | Methylprednisolone |
Primary outcome
Induced inflammatory response
Time frame: First 24 hours post cardio-pulmonary bypass
Effect of both drugs on attenuating induced inflammatory response
1 secondary outcome
Cognitive function
Time frame: First 24 hours post cardio-pulmonary bypass
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Normal saline, Dexmedetomidine and Methylprednisolone in people with Coronary Artery Disease and Systemic Inflammatory Response Syndrome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assem Abourawash, Masters (00201064013278, assemahmed999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induced inflammatory response (time frame: First 24 hours post cardio-pulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.