ABOUT THIS STUDY
1. Patient has signed and dated the Informed Consent after the study had been fully explained.
2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
3. American Society for Anesthesiologists (ASA) I to III Class.
4. Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
5. Patient undergoing a surgery requiring epidural or spinal anesthesia
1. Patient who underwent general anesthesia within 7 days, or who received other study
drugs within 30 days from the date of consent.
2. Patient with <92% SpO2, at the physical examination prior to the study drug
administration, or ventilatory failure which requires intubation or Laryngeal Mask.
3. Patient with central nervous system pathology which may lead to increased intracranial
pressure, uncontrolled seizures, psychiatric disorder which may be confused with the
response to sedation treatment.
4. Patient who require general anesthesia.
5. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven
days of scheduled surgery or procedure.
6. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used
in the study are contraindicated.
7. Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks
from the date of consent.
8. Patient whose heart rate is <60 bpm, systolic blood pressure is <90 mmHg by the
physical examination prior to the study drug administration.
9. Patient has third degree heart block, unless the patient has a pacemaker or transverse
pacing wires are in place.
10. Patient who has experienced an increase in alanine transaminase (ALT) and / or
aspartate aminotransferase (AST) more than double the upper normal limit within 2
months of the date of consent, or who has a history of liver insufficiency.
11. Pregnant or lactating woman.
12. In the Investigator's or subinvestigator's opinion, the patient has any symptom or
condition which might increase risk to the patient by conducting the study or preclude
obtaining satisfactory study data
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