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Not yet recruiting NCT07101367

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

Phase I / Phase II Interventional Coronary Artery Disease Systemic Inflammatory Response Syndrome Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normal saline, Dexmedetomidine, Methylprednisolone.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Systemic Inflammatory Response Syndrome, Postoperative Complications. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug 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
  • 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
  • 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

Primary outcome measures

  • Induced inflammatory response [Time frame: First 24 hours post cardio-pulmonary bypass]
Secondary outcome measures (1)
  • Cognitive function [Time frame: First 24 hours post cardio-pulmonary bypass]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07101367 · FMASU MD219/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗