Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
Condition: Sedation
Intervention: Dexmedetomidine hydrochloride; Placebo
Intervention description: Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Sedation; Non-intubation; epidural anesthesia; spinal anesthesia

Summary:

      The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine)
      in patients who require sedation during the surgery that requires epidural or spinal
      anesthesia without intubation under monitored sedation care.
    

Eligibility criteria:

        Inclusion Criteria:

          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

        Exclusion Criteria:

          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