Phase 3
Completed N=119
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
Sedation
Source: ClinicalTrials.gov NCT01438957 ↗
Enrolled (actual)
119
Serious AEs
0.8%
Results posted
Mar 2021
Primary outcomePrimary: 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. — 22.7; 13.0; 45.8; 68.0 Percentage of participants — p=<0.001
◆ Published Evidence
Emerging
3citations · ~1 / year
The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study.
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.
Linked Publications
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The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
22.7; 13.0; 45.8; 68.0; 80.0 | <0.001 sig |
| SECONDARY Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration |
5.1; 3.7; 1.9; 0.8; 0.5 | <0.001 sig |
| SECONDARY Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration |
1.019; 0.744; 0.373; 0.166; 0.096 | <0.001 sig |
| SECONDARY Time to First Rescue Administration of Propofol |
25.5; 20; 24; NA; NA | <0.001 sig |
| SECONDARY Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration |
95.5; 91.3; 100.0; 96.0; 96.0 | 0.869 |
| SECONDARY Number of Fentanyl Dosing Required During the Study Drug Administration. |
0.1; 0.2; 0.0; 0.0; 0.1 | 0.897 |
| SECONDARY Dosage of Fentanyl Dosing Required During the Study Drug Administration. |
0.068; 0.085; 0.000; 0.018; 0.061 | 0.897 |
| SECONDARY Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion |
50.17; 58.15; 61.44; 70.07; 76.78 | <0.001 sig |
| SECONDARY Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion |
47.88; 56; 53.66; 65.3; 62.25 | 0.088 |
| SECONDARY Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion |
15; 15; 15; 15; 15 | 0.085 |
| SECONDARY Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) |
5.85; 4.36; 3.73; 2.81; 2.65 | 0.005 sig |
| SECONDARY Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) |
2.05; 3.3; 1.68; 1.72; 1.47 | 0.737 |
| SECONDARY Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) |
2.35; 2.62; 1.8; 2.85; 3.12 | 0.11 |
| SECONDARY Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) |
1.48; 1.8; 1.05; 1.15; 1.17 | 0.567 |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure") |
1.7; 1.7; 1.2; 1.4; 1.3 | 0.044 sig |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery") |
1.2; 1.2; 1.2; 1.4; 1.2 | 0.729 |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time") |
1.7; 1.5; 1.3; 1.5; 1.2 | 0.082 |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery") |
2.2; 2.2; 2.2; 1.8; 2 | 0.451 |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery") |
1.6; 1.6; 1.6; 1.4; 1.7 | 0.873 |
| SECONDARY Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery") |
1.6; 1.6; 1.6; 1.3; 1.5 | 0.374 |
Eligibility Criteria
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.
- Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
- Patient whose heart rate is <60 bpm, systolic blood pressure is <90 mmHg by the physical examination prior to the study drug administration.
- Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
- 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.
- Pregnant or lactating woman.
- 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
Data sourced from ClinicalTrials.gov (NCT01438957) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.