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 Sugammadex and Decreased Time to Extubation (NCT03196167), a randomized phase 4 study. The primary outcome is Time to Extubation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03196167 |
| Phase | Phase 4 |
| Condition | Coronary Artery Bypass Graft and/or Aortic Valve Replacement Surgery |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 90 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Yale University |
| Results posted | Yes |
2. Clinical Question
Population
Postoperative patients arriving in a cardiothoracic intensive care unit after isolated coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined AVR and CABG. The registry describes 90 patients, with 68 undergoing CABG, 13 AVR, and 9 combined surgery. However, the primary outcome description specifically refers to patients who underwent isolated CABG, and the record does not clarify whether the posted primary summaries include only that subgroup or all enrolled patients.
Intervention
Sugammadex, described in the official title as a 2mg/kg dose. The study is listed as a phase 4 trial. The record describes the study pharmacy providing the study drug in a syringe.
Comparator
Placebo, delivered in a syringe according to the arm description. The trial is described as randomized, placebo-controlled, parallel-group, and quadruple-masked. The registry record does not identify which groups of people were included in the masking designation.
Primary question
Among postoperative cardiothoracic ICU patients, does assignment to sugammadex rather than placebo relate to a different time from ICU arrival to extubation? The registry lists time to extubation, measured in minutes over up to 2 weeks, as the primary outcome. It reports group medians and interquartile ranges, but no primary comparison estimate or statistical test.
3. Trial Design
This was a prospective, randomized, placebo-controlled trial with a parallel-group model. The registry identifies quadruple masking and phase 4. Yale University is listed as the sponsor. The record gives an enrollment of 90 and describes 45 patients in each group. The trial status is completed; the listed start date is 2017-05-13 and the primary completion date is 2020-10-01.
The study concerned postoperative patients following CABG, AVR, or combined AVR and CABG surgery. The primary outcome description refers to patients after isolated CABG, while the population description reports participants across all three surgery categories. The registry does not clarify whether the primary endpoint summaries represent the full enrolled population or the isolated-CABG subgroup. This matters for interpreting the target population and the relevance of the results to each surgery category.
The intervention was sugammadex and the comparator was placebo. The official title specifies a 2mg/kg dose. The arm descriptions say that the research pharmacy provided the study drug or placebo in a syringe. The registry does not detail the allocation sequence, concealment procedures, or which people were masked, so those operational aspects are not reported in the registry record.
The primary outcome was time to extubation in minutes, with a timeframe of up to 2 weeks. The registry reports a median and interquartile range for each group. It also lists secondary outcomes concerning respiratory measures, ICU and hospital stay, dysrhythmia, renal function, and postoperative CHF. Although the record lists a completed trial, it does not give a primary analysis, a statistical analysis plan, or a sample-size justification. The stated enrollment alone does not establish what effect the design was intended to detect.
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: Patients undergoing AVR, CABG or both were screened meeting preoperative inclusion criteria. Per the study design, elements of exclusion criteria incorporated intraoperative events. Patients were consented prior to the operation room with the understanding that they might be excluded depending on events in the operating room. Patients who screened and consented but did not participate in the study were not considered enrolled. A total of 90 participants were enrolled.
Overall Study
| Stage | Sugammadex | Placebo |
|---|---|---|
| STARTED | 45 | 45 |
| COMPLETED | 40 | 43 |
| NOT COMPLETED | 5 | 2 |
Analysis population for the primary outcome, as defined in the registry: Of the 90 patients that were included in the study (45 in each group), a total of 68 patients underwent CABG, 13 AVR and 9 combined AVR and CABG.
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 | Sugammadex | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 45 | 45 | 90 | |
| Age, Continuous | years | 67.0 (62.0 to 72.0) | 66.0 (59.0 to 71.0) | 67.0 (60.0 to 71.0) |
| Sex: Female, Male: Female | Participants | 8 | 5 | 13 |
| Sex: Female, Male: Male | Participants | 37 | 40 | 77 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 44 | 45 | 89 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): White | Participants | 41 | 41 | 82 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 2 |
| BMI | kg/m^2 | 29.39 (SD 4.83) | 29.55 (SD 4.61) | 29.47 (SD 4.70) |
| Smoking: Current | Participants | 7 | 8 | 15 |
| Smoking: Never | Participants | 21 | 19 | 40 |
| Smoking: Prior | Participants | 17 | 18 | 35 |
| Coexisting Medical Conditions: Hypertension | Participants | 37 | 32 | 69 |
| Coexisting Medical Conditions: COPD | Participants | 1 | 1 | 2 |
| Coexisting Medical Conditions: TIA/ Stroke | Participants | 2 | 1 | 3 |
| HBA1c | percentage of HbA1c | 6.9 (6.3 to 7.4) | 6.2 (5.8 to 7.2) | 6.6 (5.9 to 7.3) |
| Preoperative Medications: Aspirin | Participants | 37 | 33 | 70 |
| Preoperative Medications: Plavix | Participants | 2 | 2 | 4 |
| Preoperative Medications: Angiotensin-converting enzyme inhibitors or Angiotensin II receptor blockers | Participants | 30 | 23 | 53 |
| Preoperative Medications: Beta blockers | Participants | 33 | 23 | 56 |
| Preoperative Medications: Statins | Participants | 40 | 31 | 71 |
| Preoperative Medications: Other antihyperlipidemics | Participants | 7 | 5 | 12 |
| ASA Class: </= 3 | Participants | 14 | 13 | 27 |
| ASA Class: 4 or 5 | Participants | 31 | 32 | 63 |
| STS Surgery Risk Score | % | 1.58 (SD 0.80) | 1.34 (SD .49) | 1.46 (SD 0.68) |
| Type of Surgery: AVR | Participants | 5 | 8 | 13 |
| Type of Surgery: CABG | Participants | 34 | 34 | 68 |
| Type of Surgery: CABG plus AVR | Participants | 6 | 3 | 9 |
| Surgical Factors: Characteristics: Redo sternotomy | Participants | 0 | 1 | 1 |
| Surgical Factors: Characteristics: Off Pump surgery | Participants | 1 | 0 | 1 |
| Surgical Factors (Time): Cardiopulmonary Bypass time | Minutes | 89.2 (74.4 to 110.1) | 85.0 (68.8 to 95.2) | 86.0 (69.2 to 103.9) |
| Surgical Factors (Time): Cross clamp time | Minutes | 68.7 (54.0 to 84.0) | 63.6 (54.2 to 78.9) | 66.0 (54.0 to 81.6) |
6. Primary Endpoint
The registry lists the primary outcome as Time to Extubation, measured over Up to 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | minutes |
| Endpoint classification | not reduced to a single comparison |
Time to extubation measures the elapsed time until a patient is extubated, here expressed in minutes after arrival in the cardiothoracic ICU. The registry sets the observation timeframe as up to 2 weeks. This endpoint is directly related to the trial’s stated question about whether sugammadex is associated with a different time to extubation than placebo among postoperative ICU patients.
The registry reports the outcome as a median with an interquartile range. The median describes the middle of the observed time distribution, while the interquartile range describes the span from the lower to the upper quartile. These summaries can be useful when outcome times are skewed or include unusually long observations, because they do not rely on the mean and standard deviation to describe the distribution.
The posted median is 126 minutes in the sugammadex group, with an interquartile range of 84 to 274 minutes. In the placebo group, the median is 219 minutes, with an interquartile range of 121 to 323 minutes. These are descriptive group summaries. The registry record does not report a primary between-group estimate, confidence interval, or test, and it does not state whether the summaries include all surgery types or only isolated CABG patients. Therefore, the medians alone do not establish the precision or statistical significance of a treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome summaries describe shorter observed median time to extubation in the sugammadex group than in the placebo group: 126 minutes compared with 219 minutes. The interquartile ranges are 84 to 274 minutes and 121 to 323 minutes, respectively. These distributions overlap. Overlap between interquartile ranges is not itself a statistical test, and it does not establish whether a group difference is present or absent.
The registry record does not report a primary comparison estimate, confidence interval, p-value, or analysis method. Consequently, the posted summaries do not show how uncertain the between-group contrast is under a defined statistical model. A reader should distinguish the observed medians from an inferential conclusion: the former are reported, while the latter cannot be evaluated from a registry-reported primary analysis because one is not posted.
There is also uncertainty about the population represented by the primary summaries. The primary outcome description names patients after isolated CABG, but the population description covers patients after CABG, AVR, and combined AVR and CABG. It reports 68 CABG patients, 13 AVR patients, and 9 patients after combined surgery. The group summaries list 45 patients per arm, but the record does not explain whether those summaries include all surgery types or a defined subset. This limits interpretation of which postoperative population the primary results describe.
The trial is described as randomized, which is a design feature intended to support a fair comparison of assigned groups. But the registry record does not give details of the allocation process, analysis population, missing data, or statistical adjustment. The available information therefore supports a descriptive reading of the posted summaries, not a reconstruction of the trial’s full analysis. The stated enrollment and group sizes do not answer whether the trial had adequate precision for the primary question.
The registry lists secondary outcomes, and some have posted unadjusted comparisons. Those findings are exploratory in the absence of a reported multiplicity strategy and should not be treated as confirmation of the primary result. Nor do sparse event counts establish the presence or absence of meaningful differences. Overall, the posted primary medians show the observed distributional summaries by group; they do not, on their own, establish the size, precision, or statistical significance of a treatment effect.
9. Statistical Methods Explained
The registry describes a randomized, placebo-controlled, parallel-group design. In general, random allocation aims to make treatment groups comparable on average with respect to measured and unmeasured characteristics. This benefit depends on how randomization was carried out and maintained. The registry record does not report the allocation sequence or concealment procedures, so those details cannot be assessed from the record.
Quadruple masking is the registry’s designation for masking, but the record does not identify which people were masked. In general, masking can reduce the influence of expectations on care, outcome assessment, and reporting. The label alone does not show how masking was implemented or whether it remained effective.
Why report a median and interquartile range?
Time-to-extubation observations may be unevenly distributed. A median describes the central observation in an ordered distribution, and an interquartile range describes the middle portion of that distribution. These summaries are less sensitive to extreme observations than a mean and standard deviation. They do not, however, give a direct estimate of the difference between groups or quantify uncertainty in that difference. A formal comparison could use a method suited to the outcome distribution, but the registry record does not report which method, if any, was used for the primary endpoint.
The reported primary summaries are a median of 126 minutes with an interquartile range of 84 to 274 minutes for sugammadex, and a median of 219 minutes with an interquartile range of 121 to 323 minutes for placebo. No primary confidence interval or p-value is posted. A confidence interval would describe the uncertainty around a specified estimate under the assumptions of the analysis. Without that estimate and interval, precision of the primary comparison cannot be assessed from the registry record.
What do the binary-outcome comparisons describe?
For secondary binary outcomes, the posted recalculated comparisons include risk differences and, for some outcomes, relative risks and odds ratios. A risk difference expresses a difference in observed event proportions between groups. A relative risk compares those proportions as a ratio, while an odds ratio compares event odds. These are different scales and should not be read as interchangeable. The posted risk differences are unadjusted recalculations from the group counts, not necessarily the trial sponsor’s prespecified analyses. No sponsor-reported analyses are listed for those outcomes.
For New Dysrhythmia, the posted unadjusted risk difference is -0.067, with a 95% interval from -0.190 to 0.057 and p = 0.292. For Change in Renal Function, the corresponding difference is 0.044, with a 95% interval from -0.073 to 0.162 and p = 0.459. For Postoperative CHF, the risk difference is -0.022, with a 95% interval from -0.065 to 0.021 and p = 0.315. Each interval includes zero, so these estimates are compatible with no risk difference as well as with differences in either direction under the stated unadjusted calculation. They are not evidence that the groups are equivalent.
These calculations use small observed event counts, which can make estimates imprecise. In general, sparse binary data often produce wide intervals, and estimates can change appreciably with a small change in the number of events. For New Dysrhythmia and Change in Renal Function, the record also posts relative-risk and odds-ratio intervals. Their breadth reinforces that the estimates do not precisely determine the direction or magnitude of a difference.
How should the planning illustrations be read?
The record includes planning illustrations based on observed secondary effects, with two-sided significance level 0.05, equal allocation, and a normal approximation. The illustrations show participants per arm for 80% or 90% power under scenarios that detect 100%, 75%, or 50% of the observed effect. These are planning calculations, not observed power and not evidence that the trial was designed around those assumptions. The record explicitly distinguishes them from the trial’s own design; the trial’s sample-size justification is not reported in the registry record.
In general, planning calculations depend on the assumed effect, variability or event rate, significance level, allocation, and analysis method. Smaller effects generally require more information to detect with a chosen power. In binary outcomes with sparse events, planning based on an observed effect can be especially unstable because the observed estimate may be imprecise. These illustrations should therefore be treated as hypothetical scenarios, not as conclusions about what the completed trial could detect.
What cannot be determined from the posted analysis?
The registry lists zero reported analyses. It does not report the primary statistical test, an analysis population, missing-data handling, covariate adjustment, or a multiplicity plan. The primary outcome description and participant description also leave the analyzed population unclear. Without those details, a reader cannot determine whether the posted summaries correspond to an intention-to-treat analysis, a per-protocol analysis, or another population, nor can a full audit of the inferential methods be made.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan, a multiplicity strategy, or a missing-data method. It also lists zero reported analyses. As a result, the planned hierarchy among outcomes, the intended handling of repeated statistical tests, and the primary inferential procedure are not available for review. These omissions should not be filled by assuming conventional choices.
Multiplicity arises when researchers assess several outcomes or make several comparisons. In general, the more tests considered, the greater the chance that at least one result will appear unusual by chance if each test is interpreted independently. Methods to control that risk can include adjustment procedures or a prespecified hierarchy that limits which tests are confirmatory. The record does not say whether any such approach was used. The reported secondary p-values are unadjusted and therefore do not account for testing across outcomes.
The registry does not state whether participants with missing outcome data were excluded, retained through an imputation method, or handled in another way. It does not report the number of missing observations for the primary endpoint or the secondary outcomes. Missingness can affect both the amount of information available and the validity of an estimate if the likelihood of missing data is related to outcomes or group assignment. The posted group summaries do not by themselves resolve those questions.
The record also does not identify the analysis population used for the primary endpoint. It describes a primary outcome among isolated-CABG patients, while the participant description includes CABG, AVR, and combined procedures. The registry does not clarify whether the primary summaries cover the full enrolled population, a subgroup, or another defined set of patients. Nor does it specify whether the analysis followed randomized assignment regardless of treatment received.
These missing details limit reproducibility and prevent a complete assessment of bias, precision, and robustness. They do not establish that the original analysis was inappropriate; they mean that the relevant choices are not reported in the registry record.
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 |
|---|---|---|---|
| Sugammadex | 0 | 45 | 0.0% |
| Placebo | 0 | 45 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sugammadex | 0 of 45 |
| Placebo | 0 of 45 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sugammadex | 8 of 45 |
| Placebo | 9 of 45 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sugammadex | Placebo |
|---|---|---|---|
| postoperative atrial fibrillation | Cardiac disorders | 3 of 45 | 6 of 45 |
| postoperative creatinine rise greater than 0.5 mg/dl | Renal and urinary disorders | 5 of 45 | 3 of 45 |
The safety record reports zero serious adverse events affecting participants in each group and zero deaths in each group. It also reports other adverse events affecting 8 participants in the sugammadex group and 9 in the placebo group. These are the posted counts; the registry does not provide event-level descriptions for the other adverse events or list serious adverse-event terms.
These counts are descriptive and should not be interpreted as proof that the safety profiles are the same. With a limited number of participants and few reported events, the absence of recorded serious events does not rule out uncommon harms. The registry record also does not provide exposure-adjusted rates, event timing, severity details for the other events, or a formal comparison of adverse-event risks. The reported figures therefore give a limited account of what was recorded, rather than a comprehensive estimate of comparative safety.
12. What the Result Does, and Does Not, Mean
The posted primary summaries show that the median time to extubation was 126 minutes in the sugammadex group and 219 minutes in the placebo group. The reported interquartile ranges were 84 to 274 minutes and 121 to 323 minutes, respectively. These are descriptive results from the registry. They do not, by themselves, quantify the uncertainty in the difference between groups.
The registry does not report a primary between-group estimate, confidence interval, or p-value. It therefore does not establish whether the observed separation in medians is statistically distinguishable from sampling variation under a specified analysis. A difference in descriptive summaries is not automatically evidence of a causal treatment effect, even in a randomized trial; interpretation also depends on the analyzed population, missing data, and the analysis method.
The record describes a primary outcome among isolated-CABG patients but gives a participant breakdown that includes AVR and combined surgery. It does not clarify which patients contributed to the primary summaries. That ambiguity prevents a confident statement about whether the posted values apply to all enrolled surgery types or to the isolated-CABG group alone.
The secondary results are unadjusted and limited, and several listed outcomes have no numerical results in the registry record. Their confidence intervals and p-values should not be treated as confirmatory evidence, particularly because no multiplicity plan is reported. Likewise, the safety counts describe recorded events but cannot rule out uncommon harms or establish equivalent safety.
Accordingly, the registry supports a cautious descriptive account of the observed group summaries, not a definitive conclusion about efficacy, lack of efficacy, or clinical benefit. The absence of a posted inferential primary analysis is a key limitation when judging how precisely the data address the trial’s question.
13. Why This Trial Matters Statistically
This trial illustrates why a registry’s numerical result and its inferential analysis are not the same thing. The primary outcome has a median and interquartile range for each group, but no posted comparison estimate or statistical test. Readers can see the observed summaries, yet cannot use the registry record to assess the uncertainty around a formal treatment contrast.
It also illustrates the importance of a clearly defined analysis population. The primary outcome description refers to isolated CABG, while the participant description includes CABG, AVR, and combined surgery. Even when group sizes are reported, the target population represented by the primary summaries must be clear for the result to be interpreted and applied appropriately.
Finally, the record shows why secondary outcomes need context. Several unadjusted comparisons are available, but their intervals are broad and include no difference, while other listed secondary outcomes lack posted numerical results. Without a reported multiplicity strategy, those comparisons are exploratory rather than a substitute for a primary analysis. The trial is therefore a useful example of reading the registry record according to what it documents: descriptive results, limited secondary inference, and important methodological information that remains unreported.
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.
Several limitations are specific to the available record. The primary outcome is described as applying to isolated-CABG patients, yet the population description includes patients undergoing AVR and combined AVR and CABG. The record does not clarify which population is represented by the primary group summaries. This creates uncertainty about the scope of the reported endpoint.
The primary outcome is reported only through medians and interquartile ranges. No between-group estimate, confidence interval, p-value, or statistical method is reported. The reader therefore cannot evaluate the precision of the primary contrast from the registry results. The record also does not report missing outcome data or how any missingness was handled.
Although the study is listed as randomized and quadruple-masked, the registry does not describe allocation procedures or identify which people were masked. It does not report the analysis population, adjustments, protocol deviations, or a statistical analysis plan. These absences limit the ability to assess how the design was implemented and how the results were analyzed.
The secondary record is incomplete: several named outcomes have no posted numerical results, and the posted binary comparisons are unadjusted. There is no reported approach to multiplicity. The safety figures are counts without detailed event descriptions or a formal comparative safety analysis. Taken together, these record-level limitations constrain interpretation; they do not by themselves show that the trial conduct or original analyses were deficient.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sugammadex and Decreased Time to Extubation — NCT03196167.
- Registry record last updated 2022-01-14; status last verified 2022-01.
- Results first posted 2022-01-14.
- 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
NCT03196167 is a completed, phase 4, randomized, placebo-controlled, parallel-group trial sponsored by Yale University. It enrolled 90 postoperative cardiothoracic ICU patients after CABG, AVR, or combined AVR and CABG surgery, with 45 patients in each group. The official title specifies sugammadex at 2mg/kg; the comparator was placebo. The registry lists quadruple masking.
The primary outcome was time to extubation in minutes over up to 2 weeks. The posted medians were 126 minutes for sugammadex and 219 minutes for placebo, with interquartile ranges of 84 to 274 minutes and 121 to 323 minutes. No primary comparison analysis is reported. The record’s primary-outcome description and participant description leave the analyzed population unclear. Secondary comparisons and adverse-event counts are also posted, but the analysis plan, missing-data handling, and multiplicity approach are not reported in the registry record.