Sedation
Conditions
Keywords
Dexmedetomidine, Sedation, Non-intubation, epidural anesthesia, spinal anesthesia
Brief 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.
Detailed description
Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care
Interventions
DRUGDexmedetomidine hydrochloride
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
DRUGPlacebo
Sponsors
Maruishi Pharmaceutical
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes. | — |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 15 minutes after the start of study drug, if the OAA/S score is 5. | — |
| Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 15 minutes after the start of study drug, if the OAA/S score is 5. | — |
| Number of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | — |
| Dosage of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | — |
| Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 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. | — |
| Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 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. | — |
| Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8. | — |
| Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Time to First Rescue Administration of Propofol | During the study drug infusion period (≥15 minutes [Approximate]) | — |
| Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
| Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| 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) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level. |
| Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
| Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
| Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | Within 24 hours after completion of the study drug administration (as much as possible) | Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level. |
| Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | Within 24 hours after completion of the study drug administration | VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose | 22 |
| Dexmedetomidine 0.067 mcg/kg 0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 23 |
| Dexmedetomidine 0.25 mcg/kg 1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 24 |
| Dexmedetomidine 0.5 mcg/kg 3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 25 |
| Dexmedetomidine 1.0 mcg/kg 6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose | 25 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Dexmedetomidine 0.5 mcg/kg | Total | Dexmedetomidine 1.0 mcg/kg | Placebo | Dexmedetomidine 0.067 mcg/kg | Dexmedetomidine 0.25 mcg/kg |
|---|---|---|---|---|---|---|
| Age, Continuous | 60.0 years | 62.4 years | 59.3 years | 69.0 years | 60.7 years | 63.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 119 Participants | 25 Participants | 22 Participants | 23 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 38 Participants | 13 Participants | 3 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 18 Participants | 81 Participants | 12 Participants | 19 Participants | 16 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 | 0 / 24 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 19 / 22 | 21 / 23 | 24 / 24 | 22 / 25 | 25 / 25 |
| serious Total, serious adverse events | 0 / 22 | 1 / 23 | 0 / 24 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 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.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Percentage of participants |
| Dexmedetomidine 0.067 mcg/kg | 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. | 13.0 Percentage of participants |
| Dexmedetomidine 0.25 mcg/kg | 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. | 45.8 Percentage of participants |
| Dexmedetomidine 0.5 mcg/kg | 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. | 68.0 Percentage of participants |
| Dexmedetomidine 1.0 mcg/kg | 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. | 80.0 Percentage of participants |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: <0.001Mantel Haenszel
p-value: 0.003Mantel Haenszel
p-value: 0.086Mantel Haenszel
Comparison: Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.p-value: <0.001Mantel-extension test
Secondary
Dosage of Fentanyl Dosing Required During the Study Drug Administration.
Time frame: During the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | 0.068 mcg/kg | Standard Deviation 0.32 |
| Dexmedetomidine 0.067 mcg/kg | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | 0.085 mcg/kg | Standard Deviation 0.317 |
| Dexmedetomidine 0.25 mcg/kg | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | 0.000 mcg/kg | Standard Deviation 0 |
| Dexmedetomidine 0.5 mcg/kg | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | 0.018 mcg/kg | Standard Deviation 0.088 |
| Dexmedetomidine 1.0 mcg/kg | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | 0.061 mcg/kg | Standard Deviation 0.304 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.897Mantel Haenszel
Secondary
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Time frame: 15 minutes after the start of study drug, if the OAA/S score is 5.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 1.019 mg/kg | Standard Deviation 0.933 |
| Dexmedetomidine 0.067 mcg/kg | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.744 mg/kg | Standard Deviation 0.675 |
| Dexmedetomidine 0.25 mcg/kg | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.373 mg/kg | Standard Deviation 0.459 |
| Dexmedetomidine 0.5 mcg/kg | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.166 mg/kg | Standard Deviation 0.298 |
| Dexmedetomidine 1.0 mcg/kg | Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.096 mg/kg | Standard Deviation 0.231 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
p-value: 0.006Mantel Haenszel
p-value: 0.371Mantel Haenszel
Secondary
Number of Fentanyl Dosing Required During the Study Drug Administration.
Time frame: During the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Fentanyl Dosing Required During the Study Drug Administration. | 0.1 Number of dosing | Standard Deviation 0.6 |
| Dexmedetomidine 0.067 mcg/kg | Number of Fentanyl Dosing Required During the Study Drug Administration. | 0.2 Number of dosing | Standard Deviation 0.7 |
| Dexmedetomidine 0.25 mcg/kg | Number of Fentanyl Dosing Required During the Study Drug Administration. | 0.0 Number of dosing | Standard Deviation 0 |
| Dexmedetomidine 0.5 mcg/kg | Number of Fentanyl Dosing Required During the Study Drug Administration. | 0.0 Number of dosing | Standard Deviation 0.2 |
| Dexmedetomidine 1.0 mcg/kg | Number of Fentanyl Dosing Required During the Study Drug Administration. | 0.1 Number of dosing | Standard Deviation 0.6 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.897Mantel Haenszel
Secondary
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Time frame: 15 minutes after the start of study drug, if the OAA/S score is 5.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 5.1 Number of dosing | Standard Deviation 4.7 |
| Dexmedetomidine 0.067 mcg/kg | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 3.7 Number of dosing | Standard Deviation 3.4 |
| Dexmedetomidine 0.25 mcg/kg | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 1.9 Number of dosing | Standard Deviation 2.3 |
| Dexmedetomidine 0.5 mcg/kg | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.8 Number of dosing | Standard Deviation 1.5 |
| Dexmedetomidine 1.0 mcg/kg | Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | 0.5 Number of dosing | Standard Deviation 1.2 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
p-value: 0.006Mantel Haenszel
p-value: 0.329Mantel Haenszel
Secondary
Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration
Time frame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | 95.5 Percentage of participants |
| Dexmedetomidine 0.067 mcg/kg | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | 91.3 Percentage of participants |
| Dexmedetomidine 0.25 mcg/kg | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | 100.0 Percentage of participants |
| Dexmedetomidine 0.5 mcg/kg | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | 96.0 Percentage of participants |
| Dexmedetomidine 1.0 mcg/kg | Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration | 96.0 Percentage of participants |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.869Mantel Haenszel
Secondary
Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion
Time frame: 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.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 47.88 Percentage of time | Standard Deviation 25.31 |
| Dexmedetomidine 0.067 mcg/kg | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 56 Percentage of time | Standard Deviation 19.87 |
| Dexmedetomidine 0.25 mcg/kg | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 53.66 Percentage of time | Standard Deviation 17.5 |
| Dexmedetomidine 0.5 mcg/kg | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 65.3 Percentage of time | Standard Deviation 20.63 |
| Dexmedetomidine 1.0 mcg/kg | Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion | 62.25 Percentage of time | Standard Deviation 23.14 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.088Mantel Haenszel
Secondary
Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion
Time frame: 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.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 50.17 Percentage of time | Standard Deviation 23.88 |
| Dexmedetomidine 0.067 mcg/kg | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 58.15 Percentage of time | Standard Deviation 20.71 |
| Dexmedetomidine 0.25 mcg/kg | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 61.44 Percentage of time | Standard Deviation 18.28 |
| Dexmedetomidine 0.5 mcg/kg | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 70.07 Percentage of time | Standard Deviation 21.08 |
| Dexmedetomidine 1.0 mcg/kg | Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion | 76.78 Percentage of time | Standard Deviation 14.07 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: <0.001Mantel Haenszel
p-value: 0.002Mantel Haenszel
p-value: 0.116Mantel Haenszel
Secondary
Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery)
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | 1.6 Scores on a scale | Standard Deviation 0.9 |
| Dexmedetomidine 0.067 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | 1.6 Scores on a scale | Standard Deviation 1 |
| Dexmedetomidine 0.25 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | 1.6 Scores on a scale | Standard Deviation 0.6 |
| Dexmedetomidine 0.5 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | 1.3 Scores on a scale | Standard Deviation 0.7 |
| Dexmedetomidine 1.0 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level After Surgery) | 1.5 Scores on a scale | Standard Deviation 1 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.374Mantel Haenszel
Secondary
Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery)
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | 2.2 Scores on a scale | Standard Deviation 1.3 |
| Dexmedetomidine 0.067 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | 2.2 Scores on a scale | Standard Deviation 1.3 |
| Dexmedetomidine 0.25 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | 2.2 Scores on a scale | Standard Deviation 1.2 |
| Dexmedetomidine 0.5 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | 1.8 Scores on a scale | Standard Deviation 1 |
| Dexmedetomidine 1.0 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level Before Surgery) | 2 Scores on a scale | Standard Deviation 1.2 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.451Mantel Haenszel
Secondary
Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery)
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | 1.6 Scores on a scale | Standard Deviation 1.1 |
| Dexmedetomidine 0.067 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | 1.6 Scores on a scale | Standard Deviation 0.8 |
| Dexmedetomidine 0.25 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | 1.6 Scores on a scale | Standard Deviation 0.9 |
| Dexmedetomidine 0.5 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | 1.4 Scores on a scale | Standard Deviation 0.9 |
| Dexmedetomidine 1.0 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (Assess the Anxiety Level During Surgery) | 1.7 Scores on a scale | Standard Deviation 1.1 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.873Mantel Haenszel
Secondary
Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery)
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | 1.2 Scores on a scale | Standard Deviation 0.7 |
| Dexmedetomidine 0.067 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | 1.2 Scores on a scale | Standard Deviation 0.7 |
| Dexmedetomidine 0.25 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | 1.2 Scores on a scale | Standard Deviation 0.7 |
| Dexmedetomidine 0.5 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | 1.4 Scores on a scale | Standard Deviation 0.9 |
| Dexmedetomidine 1.0 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Did Not Feel Pain During the Surgery) | 1.2 Scores on a scale | Standard Deviation 0.6 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.729Mantel Haenszel
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)
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 Scores on a scale | Standard Deviation 1.1 |
| Dexmedetomidine 0.067 mcg/kg | 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) | 1.5 Scores on a scale | Standard Deviation 0.8 |
| Dexmedetomidine 0.25 mcg/kg | 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) | 1.3 Scores on a scale | Standard Deviation 0.6 |
| Dexmedetomidine 0.5 mcg/kg | 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) | 1.5 Scores on a scale | Standard Deviation 0.8 |
| Dexmedetomidine 1.0 mcg/kg | 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) | 1.2 Scores on a scale | Standard Deviation 0.4 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.082Mantel Haenszel
Secondary
Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure)
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | 1.7 Scores on a scale | Standard Deviation 0.8 |
| Dexmedetomidine 0.067 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | 1.7 Scores on a scale | Standard Deviation 1 |
| Dexmedetomidine 0.25 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | 1.2 Scores on a scale | Standard Deviation 0.4 |
| Dexmedetomidine 0.5 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | 1.4 Scores on a scale | Standard Deviation 0.7 |
| Dexmedetomidine 1.0 mcg/kg | Score Evaluation of Satisfaction and Anxiety of the Subject (I Was Satisfied With This Anesthesia Procedure) | 1.3 Scores on a scale | Standard Deviation 0.7 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.044Mantel Haenszel
p-value: 0.234Mantel Haenszel
Secondary
Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion
Time frame: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | 15 Minutes |
| Dexmedetomidine 0.067 mcg/kg | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | 15 Minutes |
| Dexmedetomidine 0.25 mcg/kg | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | 15 Minutes |
| Dexmedetomidine 0.5 mcg/kg | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | 15 Minutes |
| Dexmedetomidine 1.0 mcg/kg | Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion | 15 Minutes |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.085Log Rank
Secondary
Time to First Rescue Administration of Propofol
Time frame: During the study drug infusion period (≥15 minutes [Approximate])
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Rescue Administration of Propofol | 25.5 minutes |
| Dexmedetomidine 0.067 mcg/kg | Time to First Rescue Administration of Propofol | 20 minutes |
| Dexmedetomidine 0.25 mcg/kg | Time to First Rescue Administration of Propofol | 24 minutes |
| Dexmedetomidine 0.5 mcg/kg | Time to First Rescue Administration of Propofol | NA minutes |
| Dexmedetomidine 1.0 mcg/kg | Time to First Rescue Administration of Propofol | NA minutes |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: <0.001Log Rank
p-value: 0.001Log Rank
p-value: 0.212Log Rank
Secondary
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | 5.85 Scores on a scale | Standard Deviation 3.54 |
| Dexmedetomidine 0.067 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | 4.36 Scores on a scale | Standard Deviation 3.41 |
| Dexmedetomidine 0.25 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | 3.73 Scores on a scale | Standard Deviation 3.19 |
| Dexmedetomidine 0.5 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | 2.81 Scores on a scale | Standard Deviation 2.64 |
| Dexmedetomidine 1.0 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level) | 2.65 Scores on a scale | Standard Deviation 2.98 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.005Mantel Haenszel
p-value: 0.014Mantel Haenszel
p-value: 0.055Mantel Haenszel
Secondary
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | 2.05 Scores on a scale | Standard Deviation 2.21 |
| Dexmedetomidine 0.067 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | 3.3 Scores on a scale | Standard Deviation 3.19 |
| Dexmedetomidine 0.25 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | 1.68 Scores on a scale | Standard Deviation 1.46 |
| Dexmedetomidine 0.5 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | 1.72 Scores on a scale | Standard Deviation 2.14 |
| Dexmedetomidine 1.0 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State) | 1.47 Scores on a scale | Standard Deviation 1.41 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.737Mantel Haenszel
Secondary
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | 2.35 Scores on a scale | Standard Deviation 2.77 |
| Dexmedetomidine 0.067 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | 2.62 Scores on a scale | Standard Deviation 2.79 |
| Dexmedetomidine 0.25 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | 1.8 Scores on a scale | Standard Deviation 2.02 |
| Dexmedetomidine 0.5 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | 2.85 Scores on a scale | Standard Deviation 2.9 |
| Dexmedetomidine 1.0 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State) | 3.12 Scores on a scale | Standard Deviation 2.13 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.11Mantel Haenszel
Secondary
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Time frame: Within 24 hours after completion of the study drug administration
Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | 1.48 Scores on a scale | Standard Deviation 1.67 |
| Dexmedetomidine 0.067 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | 1.8 Scores on a scale | Standard Deviation 2.35 |
| Dexmedetomidine 0.25 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | 1.05 Scores on a scale | Standard Deviation 1.46 |
| Dexmedetomidine 0.5 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | 1.15 Scores on a scale | Standard Deviation 1.19 |
| Dexmedetomidine 1.0 mcg/kg | Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation) | 1.17 Scores on a scale | Standard Deviation 1.46 |
Comparison: The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this orderp-value: 0.567Mantel Haenszel