Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients

Inclusion Criteria:

• Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study has been fully explained
• Patient is male or female; at least 20 years of age
• Patient who is in condition of American Society of Anesthesiology (ASA) I to III Class preoperatively
• Patient is orally intubated and anticipated to require sedation for mechanical ventilation for a minimum period of 4 hours following open-heart surgery, coronary artery bypass grafting (CABG), or major vascular surgery
• If patient is female with child bearing potential, she is to be non-pregnant, and not lactating

Exclusion Criteria:

• Patient has serious central nervous system (CNS) trauma
• Patient has undergone or requires intracranial surgery during current hospitalization
• Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube
• Patient requires epidural or spinal analgesia/anesthesia after the end of surgery and during his/her ICU stay
• Patient in whom propofol or opioids are contraindicated
• Patient has known or suspected allergy to any medication that might be administered during the course of the study
• Patient is grossly obese (i.e., body mass index > 35)
• Patient is currently hospitalized for drug overdose
• Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated
• Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist
• Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU
• Terminally ill patient, whose life duration expectancy is no more or around 24 hours
• Patient is considered unable to undergo any procedure required by the protocol
• Patient with excessive bleeding which will likely require resurgery
• Patient has an ejection fraction of < 30%
• In the Investigator's opinion, patient has any symptom or factor, which might increase risk to the patient or preclude obtaining satisfactory study data