Dexmedetomidine Sedation and Cardiopulmonary Bypass

Assiut University

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Bypass Grafting

Treatments: Drug: Dexmedetomidine; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02727621

IRB000087801

Details and patient eligibility

About

Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1). No other sedative agent has this feature, and sedated patients frequently awaken in a confused state. Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.

Full description

100 patients undergoing elective CPB for coronary revascularization surgery. On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used. Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass

Exclusion criteria

• Severely impaired left ventricular function (ejection fraction <40%)
• Valvular heart disease
• Low cardiac output syndrome
• Uncontrolled rapid atrial fibrillation
• On plavix less than one week
• Severe systemic non-cardiac disease
• Infectious disease
• Poorly controlled diabetes mellitus
• patients on corticosteroids or other immunosuppressive treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Dexmedetomidine group

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Propofol group

Active Comparator group

Treatment:

Drug: propofol