Trial · NCT01438957
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
NCT01438957, Phase 3, Completed, Pfizer; results first posted 2021-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01438957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01438957
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01438957
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sedation
- Interventions
- Dexmedetomidine hydrochloride, Placebo
- First posted
- 2011-09-22
- Last updated
- 2021-03-22
- Results first posted
- 2021-03-22
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 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 | 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. | |
| Secondary | 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. | |
| Secondary | Time to First Rescue Administration of Propofol | During the study drug infusion period (≥15 minutes [Approximate]) | |
| Secondary | 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. | |
| Secondary | Number of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | |
| Secondary | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Percentage of participants | NUMBER |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Number of dosing | MEAN |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | mg/kg | MEAN |
| SECONDARY | Time to First Rescue Administration of Propofol | During the study drug infusion period (≥15 minutes [Approximate]) | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | minutes | MEDIAN |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Percentage of participants | NUMBER |
| SECONDARY | Number of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Number of dosing | MEAN |
| SECONDARY | Dosage of Fentanyl Dosing Required During the Study Drug Administration. | During the study drug administration | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | mcg/kg | MEAN |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Percentage of time | MEAN |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Percentage of time | MEAN |
| SECONDARY | 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. | Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs. | Minutes | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Placebo | 22.7 | 95% Confidence Interval 7.8 to 45.4 | Percentage of participants | |
| 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. | Dexmedetomidine 0.067 mcg/kg | 13.0 | 95% Confidence Interval 2.8 to 33.6 | Percentage of participants | |
| 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. | Dexmedetomidine 0.25 mcg/kg | 45.8 | 95% Confidence Interval 25.6 to 67.2 | Percentage of participants | |
| 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. | Dexmedetomidine 0.5 mcg/kg | 68.0 | 95% Confidence Interval 46.5 to 85.1 | Percentage of participants | |
| 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. | Dexmedetomidine 1.0 mcg/kg | 80.0 | 95% Confidence Interval 59.3 to 93.2 | Percentage of participants | |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | Placebo | 5.1 | Standard Deviation 4.7 | Number of dosing | |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | Dexmedetomidine 0.067 mcg/kg | 3.7 | Standard Deviation 3.4 | Number of dosing | |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | Dexmedetomidine 0.25 mcg/kg | 1.9 | Standard Deviation 2.3 | Number of dosing | |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | Dexmedetomidine 0.5 mcg/kg | 0.8 | Standard Deviation 1.5 | Number of dosing | |
| Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration | Dexmedetomidine 1.0 mcg/kg | 0.5 | Standard Deviation 1.2 | Number of dosing |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | STARTED | Dexmedetomidine 0.067 mcg/kg | 23 | |
| Overall Study | STARTED | Dexmedetomidine 0.25 mcg/kg | 24 | |
| Overall Study | STARTED | Dexmedetomidine 0.5 mcg/kg | 25 | |
| Overall Study | STARTED | Dexmedetomidine 1.0 mcg/kg | 25 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | COMPLETED | Dexmedetomidine 0.067 mcg/kg | 22 | |
| Overall Study | COMPLETED | Dexmedetomidine 0.25 mcg/kg | 24 | |
| Overall Study | COMPLETED | Dexmedetomidine 0.5 mcg/kg | 24 | |
| Overall Study | COMPLETED | Dexmedetomidine 1.0 mcg/kg | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 1 | 22 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Dexmedetomidine 0.067 mcg/kg | 0 | 23 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Dexmedetomidine 0.25 mcg/kg | 0 | 24 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Dexmedetomidine 0.5 mcg/kg | 0 | 25 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Dexmedetomidine 1.0 mcg/kg | 0 | 25 | |
| other | Restlessness | Psychiatric disorders | Placebo | 0 | 22 | |
| other | Restlessness | Psychiatric disorders | Dexmedetomidine 0.067 mcg/kg | 1 | 23 | |
| other | Restlessness | Psychiatric disorders | Dexmedetomidine 0.25 mcg/kg | 0 | 24 | |
| other | Restlessness | Psychiatric disorders | Dexmedetomidine 0.5 mcg/kg | 0 | 25 | |
| other | Restlessness | Psychiatric disorders | Dexmedetomidine 1.0 mcg/kg | 0 | 25 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, all-cause mortality | Dexmedetomidine 0.067 mcg/kg | 0 | 23 |
| Total, all-cause mortality | Dexmedetomidine 0.25 mcg/kg | 0 | 24 |
| Total, all-cause mortality | Dexmedetomidine 0.5 mcg/kg | 0 | 25 |
| Total, all-cause mortality | Dexmedetomidine 1.0 mcg/kg | 0 | 25 |
| Total, other adverse events | Placebo | 19 | 22 |
| Total, other adverse events | Dexmedetomidine 0.067 mcg/kg | 21 | 23 |
| Total, other adverse events | Dexmedetomidine 0.25 mcg/kg | 24 | 24 |
| Total, other adverse events | Dexmedetomidine 0.5 mcg/kg | 22 | 25 |
| Total, other adverse events | Dexmedetomidine 1.0 mcg/kg | 25 | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35221757 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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