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

ConditionsCoronary Artery Disease Systemic Inflammatory Response Syndrome Postoperative Complications

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age21-60

SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Declining to give a written informed consent.

History of allergy to the medications used in the study.

Psychiatric disorders.

Significant cognitive dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

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
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
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

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: DexmedetomidineActive comparator 1 intervention

Group C: MethylprednisoloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

Induced inflammatory response

Effect of both drugs on attenuating induced inflammatory response

Time frame

First 24 hours post cardio-pulmonary bypass

Secondary outcomes

Cognitive function

Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score

Time frame

First 24 hours post cardio-pulmonary bypass

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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