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Dexmedetomidine Sedation and Cardiopulmonary Bypass

Phase 2
Completed
Conditions
Coronary Artery Bypass Grafting
Interventions
Registration Number
NCT02727621
Lead Sponsor
Assiut University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Propofol grouppropofol-
Dexmedetomidine groupDexmedetomidine-
Primary Outcome Measures
NameTimeMethod
cardiac indexwithin intraoperative period

cardiac index measured in L/min/m2

Secondary Outcome Measures
NameTimeMethod
inotrope score1st 24 hours

appropriate score

sedation score1st 24 hours

appropriate score

heart ratewithin intraoperative period

heart rate measured in beat/min.

pulmonary capillary wedge pressurewithin intraoperative period

pulmonary capillary wedge pressure measured in mm.Hg

duration of mechanical ventilation1st week

duration of mechanical ventilation measured in hours

mean pulmonary artery pressurewithin intraoperative period

mean pulmonary artery pressure measure in mm.Hg

cardiac outputwithin intraoperative period

cardiac output measured in L/min

mean arterial blood pressurewithin intraoperative period

mean arterial blood pressure measured in mm.Hg

central venous pressurewithin intraoperative period

central venous pressure measured in mm.Hg

systemic vascular resistance indexwithin intraoperative period

systemic vascular resistance index measured in dyn.sec/cm5/m2

pulmonary vascular resistance indexwithin intraoperative period

pulmonary vascular resistance index measured in dyn.sec/cm5/m2

stroke volume indexwithin intraoperative period

stroke volume index measured in ml/m2/beat

left ventricular stroke work indexwithin intraoperative period

left ventricular stroke work index measured in gm/m2/beat

Trial Locations

Locations (1)

Faculty of Medicine

🇪🇬

Assiut, Egypt

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