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Clinical Trials/NCT02727621
NCT02727621
Completed
Phase 2

Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study

Assiut University1 site in 1 country100 target enrollmentApril 2016

Overview

Phase
Phase 2
Intervention
Dexmedetomidine
Conditions
Coronary Artery Bypass Grafting
Sponsor
Assiut University
Enrollment
100
Locations
1
Primary Endpoint
cardiac index
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Assiut University

Eligibility Criteria

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

Arms & Interventions

Dexmedetomidine group

Intervention: Dexmedetomidine

Propofol group

Intervention: propofol

Outcomes

Primary Outcomes

cardiac index

Time Frame: within intraoperative period

cardiac index measured in L/min/m2

Secondary Outcomes

  • heart rate(within intraoperative period)
  • pulmonary capillary wedge pressure(within intraoperative period)
  • mean pulmonary artery pressure(within intraoperative period)
  • cardiac output(within intraoperative period)
  • inotrope score(1st 24 hours)
  • duration of mechanical ventilation(1st week)
  • sedation score(1st 24 hours)
  • mean arterial blood pressure(within intraoperative period)
  • central venous pressure(within intraoperative period)
  • systemic vascular resistance index(within intraoperative period)
  • pulmonary vascular resistance index(within intraoperative period)
  • stroke volume index(within intraoperative period)
  • left ventricular stroke work index(within intraoperative period)

Study Sites (1)

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