Clinical trial NCT02727621: Dexmedetomidine Sedation and Cardiopulmonary Bypass
Official title: Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Bypass Grafting
Keywords: Dexmedetomidine
Cardiac
Coronary Artery Bypass Grapht
Sedation
Propofol
Intravenous Anesthetics
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: cardiac index
timeFrame: within intraoperative period
Secondary outcomes:
measure: heart rate
timeFrame: within intraoperative period
measure: mean arterial blood pressure
timeFrame: within intraoperative period
measure: central venous pressure
timeFrame: within intraoperative period
measure: pulmonary capillary wedge pressure
timeFrame: within intraoperative period
measure: mean pulmonary artery pressure
timeFrame: within intraoperative period
measure: systemic vascular resistance index
timeFrame: within intraoperative period
measure: pulmonary vascular resistance index
timeFrame: within intraoperative period
measure: stroke volume index
timeFrame: within intraoperative period
measure: left ventricular stroke work index
timeFrame: within intraoperative period
measure: cardiac output
timeFrame: within intraoperative period
measure: inotrope score
timeFrame: 1st 24 hours
measure: duration of mechanical ventilation
timeFrame: 1st week
measure: sedation score
timeFrame: 1st 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate professor, anesthesia and critical care
name: Sayed Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References: