Trial · NCT00209560
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
NCT00209560, Phase 3, Terminated, Eisai Inc.; results first posted 2012-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures. Trials, record NCT00209560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00209560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
- NCT number
- NCT00209560
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Interventions
- fospropofol disodium
- First posted
- 2005-09-21
- Last updated
- 2015-01-09
- Results first posted
- 2012-06-19
- Limitations and caveats
Analysis of results from a previous fospropofol study (3000-0410) completed during the enrollment of this study indicated that the dosing regimen needed to be re-evaluated. The study was prematurely terminated after 168 subjects were randomized.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Sedation success was assessed at 2 minute intervals until the end of the procedure | The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined. Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze |
| Secondary | Time to Fully Alert From the End of the Procedure | At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status | Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Sedation success was assessed at 2 minute intervals until the end of the procedure | The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator's decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group. | participants | NUMBER |
| SECONDARY | Time to Fully Alert From the End of the Procedure | At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status | The primary analysis for the secondary efficacy endpoint was based on the mITT population. Missing values or incomplete data were not imputed. | minutes | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Fospropofol Disodium | pPI Population Sedation Success | 94.2 | 95% Confidence Interval 94.2 | participants |
Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Midazolam | pPI Population Sedation Success | 78.6 | 95% Confidence Interval 63.2 to 89.7 | participants |
Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Fospropofol Disodium | mITT Population Sedation Success | 94.2 | 95% Confidence Interval 88.4 to 97.6 | participants |
Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation | Midazolam | mITT Population Sedation Success | 78.6 | 95% Confidence Interval 63.2 to 89.7 | participants |
| Time to Fully Alert From the End of the Procedure | Fospropofol Disodium | 8.4 | Standard Deviation 10.9 | minutes | |
| Time to Fully Alert From the End of the Procedure | Midazolam | 4.1 | Standard Deviation 5.4 | minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fospropofol Disodium | 121 | |
| Overall Study | STARTED | Midazolam | 42 | |
| Overall Study | COMPLETED | Fospropofol Disodium | 120 | |
| Overall Study | COMPLETED | Midazolam | 42 | |
| Overall Study | NOT COMPLETED | Fospropofol Disodium | 1 | |
| Overall Study | NOT COMPLETED | Midazolam | 0 |
Source ClinicalTrials.gov
Adverse events60
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 | Anal discomfort | Gastrointestinal disorders | Fospropofol Disodium | 3 | 121 | |
| other | Anal discomfort | Gastrointestinal disorders | Midazolam | 0 | 42 | |
| other | Constipation | Gastrointestinal disorders | Fospropofol Disodium | 5 | 121 | |
| other | Constipation | Gastrointestinal disorders | Midazolam | 2 | 42 | |
| other | Nausea | Gastrointestinal disorders | Fospropofol Disodium | 19 | 121 | |
| other | Nausea | Gastrointestinal disorders | Midazolam | 7 | 42 | |
| other | Pruritus ani | Gastrointestinal disorders | Fospropofol Disodium | 3 | 121 | |
| other | Pruritus ani | Gastrointestinal disorders | Midazolam | 0 | 42 | |
| other | Vomiting | Gastrointestinal disorders | Fospropofol Disodium | 7 | 121 | |
| other | Vomiting | Gastrointestinal disorders | Midazolam | 3 | 42 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fospropofol Disodium | ||
| Total, all-cause mortality | Midazolam | ||
| Total, other adverse events | Fospropofol Disodium | 104 | 121 |
| Total, other adverse events | Midazolam | 31 | 42 |
| Total, serious adverse events | Fospropofol Disodium | 1 | 121 |
| Total, serious adverse events | Midazolam | 0 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fospropofol Disodium vs Midazolam: serious adverse events |
Source Trial comparisons
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.
GET https://conductscience.org/api/trials/v1/NCT00209560
GET https://conductscience.org/api/trials/v1/NCT00209560/events?page=2