NCT02727621

Dexmedetomidine Sedation and Cardiopulmonary Bypass

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Grafting

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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.
DRUG	propofol	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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-04-04
• Last updated: 2016-09-27

Locations

1 site across 1 country: Egypt