One center's experience with the phase IIIb randomized multi center study comparing the safety and efficacy of dexmedetomidine to propofol for ICU sedation following coronary artery bypass graft surgery

The criteria for an ideal ICU sedative agent includes rapid onset of sedation, a short half life, easy arousability, anxiolysis, and absence of respiratory depression or hemodynamic side effects. Dexmedetomidine, an alpha 2 adrenergic receptor agonist has been demonstrated to induce sedation with easy arousability and have no respiratory depression or hemodynamic compromise. We participated in a Multi center open label study to compare the safety and efficacy of dexmedetomidine (Dex) to propofol (Prop) based standard of care for ICU sedation following coronary artery bypass graft (CABG) surgery. The study was formally approved by our institutional review board. Adults with coronary artery disease, scheduled to undergo CABG surgery and signed the informed consent were randomized to receive either Dex or Prop. At the end of the operative procedure, at the time of the last sternal suture, patients in the Dex group received a 20 min infusion of Dex at a rate of 3 μg/kg/hour. followed by a continuous infusion at 0.4 μg/kg/hour. The patients in the Prop group received a Prop infusion at 10 μg/kg/min. The patients were then transferred to the SICU, where the medication dose was titrated to maintain a Ramsay sedation score of 2–3 for 24 hours. Data collection included vital signs, level of consciousness, hemodynamic parameters, hematologic and biochemical surveys, Ramsay sedation score, and the nurse's assessment of the following: patient's anxiety level, quality of sedation, the patient's ability to tolerate the ICU environment, the ability to tolerate weaning and extubation, ease of communication with the patient and ease of patient management.

Results

Twenty patients were enrolled. Eighteen were studied and two were excluded because their scheduled surgery was cancelled. Ten patients received Dex; eight males and 2 females. Their mean age was 55.2 years. Eight patients received Prop; seven males and one female. Their mean age was 61.25 years. No significant hematologic or biochemical abnormality was noted in any of the patients. All the Dex patients received the highest scores for ease of sedation, ability to tolerate the ICU environment, ability to tolerate ventilator weaning and extubation, ease of communication and ease of patient management. Among patients receiving propofol, 75% received the highest scores for quality of sedation and ability to tolerate ICU environment. Fifty percent received the highest scores for ability to tolerate ventilator weaning and extubation and 62% received the highest scores for ease of communication and ease of patient management.

Conclusion

Dexmedetomidine is a safe agent for ICU sedation. It is superior to propofol for sedation among patients undergoing CABG surgery.