ABOUT THIS STUDY
1. Subject is > 18 years of age.
2. Subject is American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
3. If female, subject is non-lactating and is either:
- Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
4. Subject requires thoracic surgical procedure .
5. Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.
1. Subject has received general anesthesia within 7 days prior to study entry, has
received any experimental drug within 30 days prior to study drug administration, or
has been previously enrolled in this study.
2. Subject has central nervous system (CNS) disease with an anticipated potential for
increased intracranial pressure, an uncontrolled seizure disorder and/or known
psychiatric illness that could confound a normal response to sedative treatment.
3. Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of
the scheduled surgery/procedure.
4. Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are
5. Subject has received an IV opioid within one hour, or PO/IM opioid within four hours,
of the start of study drug administration.
6. Subject has acute unstable angina, acute myocardial infarction documented by
laboratory findings in the past six weeks, heart rate < 50 bpm, SBP < 90 mmHg, or
third-degree heart block unless patient has a pacemaker.
7. Subject has known elevated SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper
limit of normal (ULN) within the two months prior to screening, and/or a history of
8. Subject has any other condition or factor which, in the Investigator's opinion, might
increase the risk to the subject.
9. On vasodilators, i.e.,nitroglycerin, nitroprusside, or ACE inhibitors
10. on vasopressors, i.e, norepinephrine,epinephrine, or vasopressin
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- Columbia, Missouri