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

Ain Shams University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Postoperative Complications; Coronary Artery Disease; Systemic Inflammatory Response Syndrome

Treatments: Drug: Methylprednisolone; Drug: Normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07101367

FMASU MD219/2023

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Methylprednisolone

Active Comparator group

Description:

To be diluted in 10 ml normal saline then given after induction of anesthesia then followed by normal saline infusion till extubation in ICU

Treatment:

Drug: Methylprednisolone