Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surge… (NCT01438957) | Clinical Trial Compass
CompletedPhase 3
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
Japan119 participantsStarted 2011-06-03
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patient has signed and dated the Informed Consent after the study had been fully explained.
✓. Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
✓. American Society for Anesthesiologists (ASA) I to III Class.
✓. Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
✓. Patient undergoing a surgery requiring epidural or spinal anesthesia
Exclusion criteria
✕. Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
✕. Patient with \<92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
✕. 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.
✕. Patient who require general anesthesia.
✕. Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
✕. Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
What they're measuring
1
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.
Timeframe: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.