This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures. (NCT00327392), a non-randomized phase 2, phase 3 study. The primary outcome is Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00327392 |
| Phase | Phase 2, Phase 3 |
| Condition | Procedural Sedation |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 123 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eisai Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing minor surgical procedures and receiving procedural sedation. The registry record lists an enrollment of 123.
Intervention
AQUAVAN® (fospropofol disodium) Injection, studied for minimal-to-moderate sedation. The registry summary describes procedural sedation as involving an analgesic followed by a sedative, but further administration details are not reported in the registry record.
Comparator
There was no concurrent comparator group. The study is listed as non-randomized and single-group, so its participants do not form a like-for-like control comparison.
Primary question
How many patients required specified types of airway assistance during the 2 hours after sedation for a minor surgical procedure? The registry record identifies this as the primary outcome, but its numerical result is not reported in the registry record.
The question is about a safety event during procedural sedation, rather than a comparison of the sedative with another treatment. Airway assistance is clinically relevant as an outcome because it records whether patients needed specified support for the airway during the stated observation period. The registry record does not identify the types of assistance in the outcome description, nor does it give a result by assistance type.
The study also lists adverse-event information. That information describes reported safety events among participants receiving fospropofol disodium; without a comparator, it cannot establish whether event frequency differed from what would have occurred with another sedative or with another care approach. The registry record does not report an efficacy comparison or another primary question. Accordingly, the central statistical question is descriptive: what airway assistance and adverse events were recorded in this group, and how completely are those outcomes reported?
3. Trial Design
This study is registered as a phase 2 and phase 3, open-label, single-arm investigation of AQUAVAN® (fospropofol disodium) Injection. The allocation is non-randomized, masking is listed as none, and the model is single-group. Enrollment is listed as 123. The record identifies Eisai Inc. as the sponsor, gives a start date of 2006-05, and lists the study status as completed.
Because all participants belong to a single study group and no concurrent control is listed, the design is descriptive rather than a randomized comparison. Open-label status means masking is not listed; the registry record does not describe additional procedures for limiting awareness of treatment. The record does not state how participants were recruited, what eligibility criteria were used, or how the study group was assembled. Those details are not reported in the registry record.
The intervention is fospropofol disodium, with the registry listing AQUAVAN® Injection as its name. The brief summary frames the intended use as minimal-to-moderate procedural sedation during minor surgical procedures. It describes analgesia followed by a sedative as the general sequence for this type of sedation, but the record does not provide a detailed study dosing or administration schedule. That schedule is not reported in the registry record.
The primary outcome is the number of patients requiring specified types of airway assistance during a 2-hour timeframe. The record lists one outcome measure and no analyses. Although the study status is completed, a numerical result for the primary outcome is not reported in the registry record. The record also does not provide a planned sample size justification, a detailed statistical analysis plan, or an interim-analysis description. Each of these details is not reported in the registry record.
The single-group structure matters when reading the results. Counts and event descriptions can characterize what was recorded among enrolled participants, but they cannot by themselves separate the effects of the intervention from other influences or support a direct treatment comparison. The design should therefore be read as a safety study with a descriptive focus, not as a controlled estimate of relative benefit or harm.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: All subjects received fentanyl at an initial dose of 50 μg as an analgesic pretreatment 5 minutes prior to the administration of the initial dose of fospropofol disodium (also referred to as LUSEDRA and formerly known as AQUAVAN). After fentanyl administration, the venous catheter was flushed with 2 mL of sterile saline solution.
Overall Study
| Stage | Fospropofol Disodium |
|---|---|
| STARTED | 123 |
| COMPLETED | 123 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Number of patients requiring specified types of airway assistance
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Fospropofol Disodium |
|---|---|---|
| Participants analysed | 123 | |
| Age Continuous | years | 51.3 (SD 15.3) |
| Sex: Female, Male: Female | Participants | 67 |
| Sex: Female, Male: Male | Participants | 56 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | particpants | 0 |
| Race/Ethnicity, Customized: Asian | particpants | 1 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | particpants | 0 |
| Race/Ethnicity, Customized: Black or African American | particpants | 9 |
| Race/Ethnicity, Customized: White | particpants | 109 |
| Race/Ethnicity, Customized: More than one race | particpants | 0 |
| Race/Ethnicity, Customized: Unknown or Not Reported | particpants | 0 |
| Race/Ethnicity, Customized: Hispanic/Latino | particpants | 3 |
| Race/Ethnicity, Customized: Other | particpants | 1 |
| Weight (kg): <60 | participants | 18 |
| Weight (kg): >60 to <90 | participants | 69 |
| Weight (kg): >90 | participants | 36 |
| American Society of Anesthesiologists (ASA) status: P1 ( A normal healthy patient ) | participants | 33 |
| American Society of Anesthesiologists (ASA) status: P2 ( A patient with mild systemic disease ) | participants | 67 |
| American Society of Anesthesiologists (ASA) status: P3 ( A patient with severe systemic disease ) | participants | 22 |
| American Society of Anesthesiologists (ASA) status: P4 (High risk, severely compromised by disease) | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures, measured over 2 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | particpants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures. The registry describes its measurement as the number of patients requiring specified types of airway assistance, with a timeframe of 2 hours. The unit is listed as participants. This is a count outcome: it concerns how many people met the stated event definition, rather than a continuous measurement such as a score or a time average.
Airway assistance is a relevant safety measure in procedural sedation because it records whether a patient required support involving the airway during the observation period. In general, an outcome tied to a clinically observable intervention can help describe the extent of support required during care. The registry record does not specify the types of airway assistance, the precise criteria for counting a patient, or whether multiple assistance events for one patient are handled in a particular way. Those definitions are not reported in the registry record.
The endpoint is not a direct measure of sedation quality, recovery, or comparative treatment effect. Nor does its title alone indicate why assistance was needed in a given case. The record does not provide a numerical endpoint result, subgroup breakdown, or confidence interval. Consequently, the endpoint can be explained from its stated definition, but the frequency and precision of the observed outcome cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a safety-focused question: the number of patients requiring specified types of airway assistance during a 2-hour period after receiving study sedation for minor surgical procedures. However, it does not report the numerical result for this primary outcome. Without that count, the airway-assistance frequency cannot be described, and no estimate of its precision can be assessed from the posted results.
The adverse-event information gives a different kind of safety description. In the fospropofol disodium group, 4 of 123 participants are listed as affected by serious adverse events, and 111 of 123 are listed as affected by other adverse events. These are counts among the enrolled group, not comparisons against a control. The record also lists serious adverse-event terms with percentages: Atrial septal defect, 1.6%; Cardiac arrest, 0.8%; Ammonia increased, 0.8%; Hepatic encephalopathy, 0.8%; and Apnoea, 0.8%. These terms describe reported events, but the registry record does not provide enough event-level detail to determine how they relate to one another or to the primary endpoint.
A count from a single group is descriptive. In general, it can indicate how many participants in that group were recorded as experiencing an event, but it does not show what the count would have been under an alternative treatment or in the absence of the study intervention. With no concurrent comparator and no random assignment, differences from another population or another setting would not constitute a randomized treatment contrast. The posted information therefore does not establish a causal effect.
The counts also have limits in precision. In general, an estimate based on a finite group is subject to sampling uncertainty, and a confidence interval can communicate a range of values compatible with the data under a stated statistical model. No confidence interval for the primary airway-assistance outcome is reported in the registry record. The record does not report a confidence interval for the adverse-event counts either. It is therefore not possible to judge the statistical precision of those event estimates from the posted results alone.
The listed event percentages should be read as registry descriptions, not as evidence of a comparison or an explanation for an event. The registry does not supply a control-group frequency, an adjusted analysis, or a formal test of group differences. A participant may also have more than one type of event in general; the record does not clarify whether event terms overlap among participants. The serious-event percentages should not be combined or treated as mutually exclusive categories.
Overall, the record describes an enrolled group, a primary safety outcome, and adverse-event counts, but leaves the primary outcome result unreported. It also does not state whether missing outcome data occurred or how such data were handled. The completed status does not fill in those gaps. Interpretation should remain limited to the information that is actually recorded: the study design, the stated endpoint, and the posted safety counts and terms.
9. Statistical Methods Explained
Statistical interpretation begins with the design. This is a non-randomized, open-label, single-group study. In general, random assignment and a concurrent comparator can help distinguish differences associated with treatment from differences due to participant characteristics, changes over time, or other influences. Those design features are not present in the registry record. The study can describe events observed among participants, but it does not provide a randomized comparison of AQUAVAN® with another intervention.
What does a count endpoint represent?
The primary outcome is a count of patients requiring specified types of airway assistance during a 2-hour timeframe. A count is often a straightforward way to report how many people experienced a defined event. To interpret it fully, readers need a clear event definition, a denominator, and information about how outcome status was determined. The registry record identifies the unit as participants and lists enrollment as 123, but does not provide the result count or specify the types of assistance and counting rules. The primary outcome frequency therefore cannot be calculated or interpreted from the posted record.
In general, count data can be analyzed in several ways, depending on the question and the structure of the observations. A count of affected participants is different from a count of repeated events: a participant-level count records whether each person met the definition, while an event-level count may include multiple events for one person. The registry wording refers to the number of patients. It does not report whether repeated assistance episodes were recorded separately or how they were classified.
Why does the absence of a comparator matter?
With one study group, a result is a description of that group. A comparison would require a suitable reference group and a defined contrast. General statistical methods for comparing groups can account for sampling variation, but they cannot create a control group that the design did not include. In this study, the posted adverse-event counts cannot be interpreted as excess risk, reduced risk, or a treatment difference because no concurrent comparator is listed. Comparisons to other studies would also require caution because populations, definitions, observation periods, and reporting practices may differ.
The open-label designation is another design feature to consider. In general, awareness of the intervention can influence reporting or assessment, particularly when outcomes involve judgment. The registry record lists masking as none but does not describe outcome-assessment procedures or safeguards. It is not possible to determine from the record whether assessment was standardized or independently reviewed.
What do the adverse-event counts show?
The record lists 4 of 123 participants as affected by serious adverse events and 111 of 123 as affected by other adverse events. These figures are descriptive counts for the named study group. The registry also lists five serious adverse-event terms and their percentages. In general, event summaries depend on definitions, coding, observation windows, and whether the unit is people or events. The record does not give detailed definitions or event-level listings, so the listed terms cannot be used to infer causes, timing, duration, or overlap among participants.
A confidence interval, in general, describes statistical uncertainty around an estimate under specified assumptions. It does not remove design limitations, and it does not establish causation. No confidence interval for the primary endpoint or the adverse-event summaries is reported in the registry record. No formal analysis results are listed; the record reports 0 analyses. As a result, no inferential estimate or test can be interpreted from the posted analysis record.
How should planning calculations be read?
Planning calculations are not observed outcomes. In general, a sample-size illustration estimates the number of participants that might be needed under a set of assumptions about an effect, significance level, allocation, and statistical method. The registry record does not report that such an illustration was the study's design justification. Any planning illustration associated with the results is separate from the enrolled study and must not be read as observed power.
The planning assumptions described for such illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. For non-time-to-event outcomes, results are expressed as participants per arm for 80% power or another stated power level; time-to-event planning uses total events. These are hypothetical two-arm planning assumptions, not the actual single-group, non-randomized design. The record does not report the study's own sample-size justification. The specific planning values are not reported in the registry record.
Finally, no analysis population, handling of missing observations, or interim-analysis approach is reported in the registry record. These omissions limit the ability to connect the enrollment count to the number of participants contributing to each outcome. The completed status alone does not indicate completeness of outcome data or the methods used to analyze them.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and 0 analyses. It identifies airway assistance as the primary outcome, but does not report a numerical result for that endpoint. No secondary outcome results or analysis details are listed. A formal multiplicity strategy—such as a hierarchy for testing multiple outcomes or an adjustment for multiple statistical tests—is not reported in the registry record. Given the absence of listed analyses, the record does not allow readers to assess whether multiplicity was considered in the study's analysis plan.
Missing-data information is also not reported in the registry record. The record does not state how many participants had missing outcome observations, whether all enrolled participants were assessed during the stated timeframe, or how missing information was handled. In general, missingness can affect an estimate when participants with unavailable outcomes differ from those with recorded outcomes. The direction and extent of any such effect cannot be assessed without information about missingness and the analysis approach.
The analysis populations are not reported in the registry record. It is not stated whether the primary outcome was evaluated among all enrolled participants, among participants who received the intervention, or within another defined group. The adverse-event group lists 123 participants at risk, but this does not by itself define the population used for the primary outcome or establish completeness of follow-up.
No interim-analysis plan or early-stopping rule is reported in the registry record. The study is listed as completed, but that status does not establish whether interim reviews occurred. These reporting gaps mean that readers cannot determine the prespecified analysis population, assess missing-outcome handling, or evaluate any adjustment for multiple analyses.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fospropofol Disodium | 4 | 123 | 3.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fospropofol Disodium | 111 of 123 |
Most frequent serious adverse event terms
| Event term | Organ system | Fospropofol Disodium |
|---|---|---|
| Atrial septal defect | Congenital, familial and genetic disorders | 2 of 123 |
| Cardiac arrest | Cardiac disorders | 1 of 123 |
| Ammonia increased | Investigations | 1 of 123 |
| Hepatic encephalopathy | Nervous system disorders | 1 of 123 |
| Apnoea | Respiratory, thoracic and mediastinal disorders | 1 of 123 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fospropofol Disodium |
|---|---|---|
| Paresthesia | Nervous system disorders | 66 of 123 |
| Procedural pain | Injury, poisoning and procedural complications | 62 of 123 |
| Pruritus | Skin and subcutaneous tissue disorders | 32 of 123 |
| Nausea | Gastrointestinal disorders | 10 of 123 |
| Vomiting | Gastrointestinal disorders | 7 of 123 |
| Hypotension | Vascular disorders | 5 of 123 |
| Headache | Nervous system disorders | 4 of 123 |
| Uterine spasm | Reproductive system and breast disorders | 4 of 123 |
| Constipation | Gastrointestinal disorders | 3 of 123 |
| Dizziness | Nervous system disorders | 3 of 123 |
Serious events with the highest arm-level rate: atrial septal defect (1.6%), cardiac arrest (0.8%), ammonia increased (0.8%), hepatic encephalopathy (0.8%), apnoea (0.8%).
The registry lists a fospropofol disodium group with 123 participants at risk for serious adverse events and 4 participants affected. For other adverse events, it lists 123 at risk and 111 affected. These are participant counts as recorded in the safety summary. The record does not provide a comparator group, so the counts describe this study group rather than a difference between treatments.
The serious adverse-event terms listed are Atrial septal defect, 1.6%; Cardiac arrest, 0.8%; Ammonia increased, 0.8%; Hepatic encephalopathy, 0.8%; and Apnoea, 0.8%. These percentages are registry entries. They should not be summed, interpreted as mutually exclusive, or used to infer the number of distinct participants represented by all terms. The record does not provide participant-level detail to establish whether one person had more than one listed event.
The registry does not report deaths in the safety entry; the death value is not reported in the registry record. It also does not provide event timing, duration, outcome, severity criteria beyond the serious classification, or a causal assessment. The counts therefore offer a limited descriptive view of reported safety events and cannot determine their cause or comparative frequency.
12. What the Result Does, and Does Not, Mean
The study provides a registry record of an open-label, single-group investigation of fospropofol disodium for sedation during minor surgical procedures. It identifies a primary safety outcome—patients requiring specified types of airway assistance during a 2-hour timeframe—and reports adverse-event counts for the study group. These details establish what the study was intended to describe and give some information about reported safety events.
The primary outcome result itself is not reported in the registry record. That omission prevents a reader from determining how many participants required airway assistance, how common the event was in this study group, or how precisely that frequency was estimated. The absence of a reported result is not evidence that no such events occurred.
The serious and other adverse-event counts are descriptive, not comparative. Without a control group, the study cannot show whether those counts were higher or lower than they would have been under another treatment or care approach. The record also does not provide an analysis that attributes events to the intervention. The posted data therefore do not establish that the intervention caused or prevented any specific event.
In general, a completed study can still have reporting gaps in its registry record. The completed status does not substitute for a primary-outcome result, a statistical analysis, a confidence interval, or a description of missing data. The record does not report the analysis population, endpoint definitions beyond the brief wording, or a detailed statistical plan. Those gaps constrain what can be concluded from the registered information.
The findings should be understood as a limited descriptive account of one study group. They do not establish comparative effectiveness, comparative safety, or the likelihood of an outcome in a different patient population. The registry record supports identification of the study question and selected safety summaries, while leaving the central airway-assistance result and key analytic details unreported.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a safety question and a comparative treatment question. The primary endpoint asks for a count of patients requiring airway assistance within a specified timeframe. That kind of endpoint can be clinically interpretable as a description of events in the studied group, provided the event definition and result are available. Here, the registry record gives the endpoint description but not its numerical result, so the intended safety measure cannot be evaluated from the posted record.
The single-group design also clarifies the limits of inference. Descriptive event counts can summarize what was recorded among participants, but a randomized comparator is generally needed to make a direct treatment contrast less vulnerable to differences between groups. Since no such comparator is listed, the adverse-event counts cannot be read as evidence of a relative increase or decrease in events. This distinction is important when interpreting safety information: observed events and treatment-attributable effects are not the same thing.
The record further shows why statistical reporting involves more than a sample size and a list of outcomes. Interpretation depends on outcome definitions, analysis populations, missing-data handling, uncertainty estimates, and the prespecified approach to analysis. Those details are not reported in the registry record. Without them, readers cannot fully judge how the endpoint was measured or how precise its estimated frequency would be.
Finally, any sample-size planning illustration is conceptually separate from the study's observed results. Planning assumptions describe a hypothetical design calculation, not statistical power observed after the study. In this case, the listed planning framework assumes a two-arm calculation, while the registered study is single-group. Keeping that distinction clear prevents a planning scenario from being mistaken for evidence about the actual study's design or results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation in interpreting this trial record is that the primary outcome result is not reported in the registry record. The endpoint is described as the number of patients requiring specified types of airway assistance during 2 hours, but no count or uncertainty estimate is posted. The record also does not specify the types of assistance or detailed event criteria, which limits understanding of what qualified as an outcome event.
The single-group, non-randomized design does not include a concurrent control. It therefore supports description of events in the study group, but not a controlled estimate of relative safety or treatment effect. The open-label status and absence of masking are recorded, while the procedures used to assess outcomes are not reported in the registry record. Potential influences on event recognition or reporting cannot be assessed from the available details.
The safety summaries provide counts and selected serious-event terms, but no participant-level listings, timing, event duration, outcomes, or causal assessments. The registry does not clarify whether listed event categories overlap. Death information is not reported in the registry record. These limitations prevent a fuller interpretation of the safety profile from the registered summary alone.
Other important analytic details are not reported in the registry record: eligibility criteria, treatment administration details, the analysis population, missing-data handling, confidence intervals, and the statistical analysis plan. Although the study is marked completed, the record does not state whether all participants contributed outcome data or whether interim analyses occurred. These gaps limit assessment of the representativeness, completeness, and precision of the results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures. — NCT00327392.
- Registry record last updated 2012-06-20; status last verified 2012-05.
- Results first posted 2012-06-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00327392 is a completed, open-label, non-randomized, single-group study of AQUAVAN® (fospropofol disodium) Injection for minimal-to-moderate sedation during minor surgical procedures. The record lists phase 2 and phase 3, enrollment of 123, sponsor Eisai Inc., and a start date of 2006-05.
The primary outcome is the number of patients requiring specified types of airway assistance during 2 hours. Its numerical result is not reported in the registry record. The safety summary lists 4 of 123 participants affected by serious adverse events and 111 of 123 affected by other adverse events. No analyses are listed. Key details about the analysis population, missing data, outcome definitions, and statistical plan are not reported in the registry record.