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Dexmedetomidine Sedation and Cardiopulmonary Bypass

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02727621
Enrollment
100
Registered
2016-04-04
Start date
2016-04-30
Completion date
2016-09-30
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting

Keywords

Dexmedetomidine, Cardiac, Coronary Artery Bypass Grapht, Sedation, Propofol, Intravenous Anesthetics

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.

Interventions

DRUGDexmedetomidine

Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

DRUGpropofol

Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cardiac indexwithin intraoperative periodcardiac index measured in L/min/m2

Secondary

MeasureTime frameDescription
pulmonary vascular resistance indexwithin intraoperative periodpulmonary vascular resistance index measured in dyn.sec/cm5/m2
stroke volume indexwithin intraoperative periodstroke volume index measured in ml/m2/beat
left ventricular stroke work indexwithin intraoperative periodleft ventricular stroke work index measured in gm/m2/beat
cardiac outputwithin intraoperative periodcardiac output measured in L/min
inotrope score1st 24 hoursappropriate score
duration of mechanical ventilation1st weekduration of mechanical ventilation measured in hours
systemic vascular resistance indexwithin intraoperative periodsystemic vascular resistance index measured in dyn.sec/cm5/m2
sedation score1st 24 hoursappropriate score
heart ratewithin intraoperative periodheart rate measured in beat/min.
mean arterial blood pressurewithin intraoperative periodmean arterial blood pressure measured in mm.Hg
central venous pressurewithin intraoperative periodcentral venous pressure measured in mm.Hg
pulmonary capillary wedge pressurewithin intraoperative periodpulmonary capillary wedge pressure measured in mm.Hg
mean pulmonary artery pressurewithin intraoperative periodmean pulmonary artery pressure measure in mm.Hg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026