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NCT Number: NCT02727621

Dexmedetomidine Sedation and Cardiopulmonary Bypass

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.

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Key information

Conditions

Coronary Artery Bypass Grafting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: precedex

Propofol

Drug

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.

Other names: diprivan

Primary outcomes

  1. cardiac index

    Time frame: within intraoperative period

    cardiac index measured in L/min/m2

Secondary outcomes

  1. heart rate

    Time frame: within intraoperative period

    heart rate measured in beat/min.

  2. mean arterial blood pressure

    Time frame: within intraoperative period

    mean arterial blood pressure measured in mm.Hg

  3. central venous pressure

    Time frame: within intraoperative period

    central venous pressure measured in mm.Hg

  4. pulmonary capillary wedge pressure

    Time frame: within intraoperative period

    pulmonary capillary wedge pressure measured in mm.Hg

  5. mean pulmonary artery pressure

    Time frame: within intraoperative period

    mean pulmonary artery pressure measure in mm.Hg

  6. systemic vascular resistance index

    Time frame: within intraoperative period

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

  7. pulmonary vascular resistance index

    Time frame: within intraoperative period

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

  8. stroke volume index

    Time frame: within intraoperative period

    stroke volume index measured in ml/m2/beat

  9. left ventricular stroke work index

    Time frame: within intraoperative period

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

  10. cardiac output

    Time frame: within intraoperative period

    cardiac output measured in L/min

  11. inotrope score

    Time frame: 1st 24 hours

    appropriate score

  12. duration of mechanical ventilation

    Time frame: 1st week

    duration of mechanical ventilation measured in hours

  13. sedation score

    Time frame: 1st 24 hours

    appropriate score

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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