Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation (NCT05216991), a registered phase not stated study. The primary outcome is Incidence of Postoperative Residual Weakness in the Recovery Room.

2. Clinical Question

3. Trial Design

The registry record identifies this study as “Sugammadex and Quantitative Monitoring in ‘Fast-Track Anesthesia’ During Liver Transplantation.” Mayo Clinic is listed as the sponsor. The recorded enrollment is 97. The study started on 2022-10-20, has a primary completion date of 2025-01-21, and is marked COMPLETED.

The two described groups both receive sugammadex after liver transplantation, with quantitative monitoring described as standard of care. Their distinguishing feature is the monitoring hand: dominant or non-dominant. The listed interventions are TetraGraph monitoring on each of those hands. Allocation is not stated. The registry record also cautions that the arms are not a like-for-like control comparison. The descriptions therefore do not establish a randomized treatment comparison, nor do they establish that one hand-placement group is an untreated control.

The primary outcome is a participant count for postoperative residual weakness in the recovery room. The recorded timeframe is approximately 10 minutes of the surgery recovery period. Four outcome measures are listed in the record, including ICU admission, hospital length of stay, and postoperative pulmonary complications as secondary outcomes. The posted information does not give results for those outcomes.

Although the study is marked completed, the registry record lists zero analyses and does not include a reported primary outcome result. It also does not report the allocation process, a detailed statistical analysis plan, or a sample-size justification. These omissions limit what can be concluded about how the study was conducted and what it found; completion status alone does not supply the missing outcome estimates.

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: 67 participants screen failed prior to randomization.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Incidence of Postoperative Residual Weakness in the Recovery Room, measured over Approximately 10 minutes of surgery recovery period.

The primary endpoint is the number of participants with postoperative residual weakness in the recovery room. The registry defines residual weakness as a train-of-four ratio below 0.9. The train-of-four test delivers four consecutive stimuli to a nerve and assesses the muscle response. The ratio compares the amplitude of the fourth twitch with the first. The registry describes a ratio equal to or greater than 0.9 as indicating no residual weakness.

The measurement is made with an electromyographic device placed on the thumb. The record says this device is also part of standard care for intraoperative assessment of muscle weakness. The planned assessment timeframe is approximately 10 minutes of the surgery recovery period. The endpoint therefore focuses on a measured physiological sign at a specified postoperative stage, rather than on a later functional outcome or a participant-reported symptom.

As a count endpoint, the result would describe how many participants crossed the registry’s threshold. The count alone would not explain the severity or duration of weakness, nor would it establish why a participant had a low ratio. General statistical context: a threshold converts a continuous measurement into an event category. That can make the clinical question easier to state, but it also means that observations near the cut-off may be classified differently from those just on the other side.

The registry record does not post the primary endpoint count, the number assessed, or a confidence interval. The intended measure is clear, but the frequency and precision of the observed result cannot be evaluated from the posted outcome information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical context: the first step in interpreting a trial result is to identify the outcome, the population included in its analysis, and the comparison being made. For this study, the registered primary outcome is a count of participants with postoperative residual weakness, defined by a train-of-four ratio below 0.9. The record names two monitoring groups, distinguished by dominant- versus non-dominant-hand placement. However, the allocation process is not stated, and the record cautions that the arms are not a like-for-like control comparison. That warning limits causal interpretation of any group contrast.

What does a count endpoint tell the reader?

The endpoint counts participants who meet a prespecified threshold. A count is directly interpretable as the number of observed participants meeting that definition, but it is not enough to establish a frequency unless the relevant denominator is also known. The record gives total enrollment of 97, but does not report the primary outcome count or the number assessed for that outcome. Enrollment should not automatically be treated as the endpoint denominator: participants can have unavailable measurements or other reasons for not contributing to an analysis, and the registry record does not describe how such cases were handled.

General statistical context: when a count is converted to a proportion, the denominator and the population to which it refers are essential. A confidence interval can express sampling uncertainty around an estimated proportion, but it cannot correct for incomplete measurement, selection into the analysis, or differences between groups. No primary estimate or interval is posted in the registry record, so these features cannot be evaluated for this endpoint.

How should the two monitoring groups be understood?

The groups are described as receiving sugammadex and quantitative monitoring as standard of care. The monitoring device is placed on the dominant hand in one group and the non-dominant hand in the other. This is not a comparison of sugammadex with a different medication, and neither arm is described as receiving no monitoring. Since allocation is not stated, the record does not establish that participants were assigned at random. Its warning that the groups are not a like-for-like control comparison is important: observed group differences, if available, could reflect differences other than hand placement.

General statistical context: random allocation, when used and properly implemented, can help balance known and unknown participant characteristics between groups on average. Without a reported allocation method, readers cannot assume that protection. A descriptive comparison can still report what was observed in each group, but causal claims require stronger design and analysis support than a difference in counts alone.

What do the recorded analysis details establish?

The registry lists four outcome measures and zero analyses. It does not report the model or test used for the primary outcome, whether results were adjusted for any covariates, or how uncertainty was quantified. It also does not report a statistical analysis plan. These omissions mean that no specific inferential procedure can be attributed to the study from this record.

The record includes assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. These are described as planning illustrations based on an observed effect, not as the trial’s own design. The record does not state that these assumptions were the basis for the trial’s enrollment. Nor does an illustration of sample size establish the study’s actual power or the probability that a result is true. Sample-size illustrations are planning aids, not observed outcomes or observed power.

General statistical context: a two-sided test considers departures in either direction from a null hypothesis. A significance level is a threshold used within a testing procedure; it is not the probability that the null hypothesis is true. A normal approximation is a mathematical method that can be used to estimate sampling behavior under particular conditions. Whether it is suitable depends on the data and analysis. The registry record does not provide enough analysis detail to judge those conditions for this study.

Why do outcome definition and timing matter?

The registry describes the threshold and the approximate recovery-room timeframe. Timing matters because a measurement at one point in recovery may not describe measurements later in the hospital course. The primary outcome is therefore specific to the recorded assessment window, rather than a general measure of all postoperative weakness. The record does not report repeated measurements, the handling of measurements outside the stated timeframe, or whether all participants were assessed at the same time.

General statistical context: a clearly defined outcome supports consistent classification across participants. Measurement quality, timing, and missingness still affect interpretation. The registry’s description of the electromyographic assessment clarifies what is intended to be measured, but the posted record does not provide results with which to assess the observed distribution or measurement completeness.

Overall, the available design and analysis information supports describing the registered question, endpoint definition, groups, and planning assumptions. It does not support estimating the frequency of residual weakness, comparing outcome rates, judging precision, or assessing the adequacy of the statistical analysis for the observed data.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("TetraGraph monitoring on dominant hand", "TetraGraph monitoring on non-dominant hand")
n      <- c(15, 15)
events <- c(2, 0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  TetraGraph monitoring on dominant hand  15  2  13.3  1.7  40.5  3.7  37.9  4.0  38.3
ARM  TetraGraph monitoring on non-dominant hand  15  0  0.0  0.0  21.8  0.0  20.4  0.2  20.6

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures. The primary outcome is postoperative residual weakness in the recovery room; the secondary outcomes include ICU admission, hospital length of stay, and postoperative pulmonary complications. The record does not report how many statistical hypotheses were tested, whether outcomes were ranked in advance for interpretation, or whether any adjustment was planned for multiple comparisons. A multiplicity strategy is not reported in the registry record.

General statistical context: when several outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if each is interpreted using an unadjusted threshold. Methods for addressing multiplicity can change how evidence is summarized. Without a reported analysis plan or outcome analyses, readers cannot determine whether or how multiplicity was handled in this study. The listing of several outcomes alone does not show that each was tested or that a particular adjustment was used.

The posted record does not describe missing-data rules for the primary or secondary outcomes. It does not report how many enrolled participants had endpoint measurements, reasons for any absent measurements, or whether any imputation or sensitivity analysis was performed. The enrollment of 97 should not be taken as proof that all 97 contributed to each outcome analysis.

The analysis population is also not described. The record does not say whether analyses included all enrolled participants, only participants with a recorded measurement, or another defined population. These details affect the interpretation of outcome counts and any comparison. The absence of these details is not evidence that data were missing or that any particular analysis population was used; those matters are not reported in the registry record.

Zero analyses are listed in the registry. This means there are no posted analysis results to evaluate for multiplicity or missing-data handling. It does not establish that no analyses were conducted elsewhere.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports adverse-event figures for the two monitoring groups, with 15 participants at risk in each group. Serious adverse events affected 0 participants in the dominant-hand group and 0 in the non-dominant-hand group. Other adverse events affected 2 participants in the dominant-hand group and 0 in the non-dominant-hand group. Deaths are reported as 0 in both groups. No top serious adverse-event terms are listed.

These are counts for the groups and risk sets recorded in the adverse-event information. They should not be confused with the total enrollment of 97 or assumed to describe all enrolled participants; the registry record does not explain why the reported at-risk counts are 15 in each group. The record also does not provide the specific terms for the other adverse events, their severity, timing, or relationship to study procedures.

General statistical context: small event counts provide limited information about the range of plausible event frequencies. A zero count means no event was recorded in that reported group and category; it does not prove that the underlying risk is zero. Because the registry record does not post a safety analysis or detailed event descriptions, these figures support only a limited descriptive reading, not a comparative safety conclusion.

13. What the Result Does, and Does Not, Mean

The registry record establishes the study’s central measurement question: how many liver-transplant patients receiving sugammadex have a train-of-four ratio below 0.9 during recovery-room assessment. It also describes quantitative monitoring on either the dominant or non-dominant hand. Those details clarify what was intended to be measured and how the groups were characterized.

The posted record does not report the primary endpoint count, the number assessed, a primary outcome estimate, or a confidence interval. It therefore does not establish the observed frequency of residual weakness or the precision of that frequency. The registry’s COMPLETED status does not substitute for an outcome result.

The group descriptions also do not support a causal comparison. Both groups are described as receiving sugammadex and quantitative monitoring, allocation is not stated, and the registry warns that the arms are not a like-for-like control comparison. Even if group counts were available, a contrast would need to be interpreted in light of those design limitations and any relevant differences between groups.

General statistical context: an outcome count describes observations under a particular measurement definition and timeframe. It does not, on its own, show that an intervention caused an outcome or establish how a finding applies to people outside the studied population. A threshold-based measure also does not describe every aspect of weakness or its course over time.

The listed secondary outcomes indicate that ICU admission, hospital length of stay, and postoperative pulmonary complications were also of interest. Their results are not reported in the registry record. The safety figures are limited to the adverse-event counts recorded for groups of 15 participants at risk each, and no detailed terms are listed for the other adverse events. In sum, the record describes the question and some design and safety information, but it does not post enough results to determine the primary outcome or draw a treatment-effect conclusion.

14. Why This Trial Matters Statistically

This study is statistically notable for defining a measurable recovery-room endpoint rather than relying only on a broad description of postoperative weakness. The train-of-four ratio threshold below 0.9 provides an operational event definition, while the approximately 10-minute recovery period specifies the intended assessment window. These features make the question more concrete, although the registry record does not post the resulting endpoint count.

The record also illustrates why the structure of a comparison matters. The two groups differ in monitoring hand, but both are described as receiving sugammadex and quantitative monitoring. Allocation is not stated, and the registry cautions against treating the arms as a like-for-like control comparison. A numerical contrast, if available, would need to be distinguished from a causal estimate.

General statistical context: interpreting a clinical result requires more than a point estimate. Readers need to know the denominator, missing-data handling, analysis population, and uncertainty. These elements help establish what population an estimate describes and how much precision it carries. They are not reported for the primary endpoint in this registry record.

The record’s status and enrollment information are useful for describing the study, but they do not resolve the absence of posted outcome analyses. The contrast between a completed study and zero analyses listed in the record underscores that study status, outcome reporting, and statistical inference are different pieces of information. Without outcome estimates, readers cannot evaluate the observed frequency, compare groups, or assess precision.

The study therefore matters statistically as an example of the need to align a well-defined measurement with transparent reporting of who was measured, what was observed, and how uncertainty was handled. The registry record supplies the endpoint definition and group descriptions, while leaving those result and analysis details unreported.

15. 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 primary limitation for interpretation is that the registry record does not post the primary outcome result. It gives no count of participants meeting the residual-weakness definition, no endpoint denominator, and no confidence interval. The frequency and precision of the primary outcome therefore cannot be assessed.

The record reports enrollment of 97 but does not explain how many participants contributed to the primary or secondary outcomes. It does not report missing measurements, reasons for missingness, or the analysis population. This prevents readers from determining whether outcome counts, if later reported, would represent all enrolled participants or a subset.

The group allocation process is not stated. The two groups are characterized by monitoring on different hands, and the registry explicitly cautions that they are not a like-for-like control comparison. The record therefore does not support interpreting a between-group contrast as a causal effect of monitoring hand or of sugammadex.

The registry lists four outcome measures but zero analyses. It does not report the statistical model, adjustment strategy, multiplicity approach, or detailed statistical analysis plan. A sample-size justification for the trial is not reported in the registry record. The planning assumptions recorded for sample-size illustrations are not described as the trial’s own design assumptions.

For safety, the at-risk count is 15 in each group, and detailed terms for the other adverse events are not listed. The record does not explain the relationship between those safety counts and total enrollment. These limitations are specific to the posted information and do not establish what may or may not be available outside the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation — NCT05216991.
• Registry record last updated 2025-10-24; status last verified 2025-09.
• Results first posted 2025-10-24.
• 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.

19. Record Summary

The registry record describes a completed Mayo Clinic study of sugammadex and quantitative monitoring during liver transplantation. Enrollment is 97. The groups are described as receiving sugammadex and monitoring with TetraGraph on either the dominant or non-dominant hand; allocation is not stated, and the groups are not described as a like-for-like control comparison.

The primary endpoint is the count of participants with postoperative residual weakness in the recovery room, defined as a train-of-four ratio below 0.9 during approximately 10 minutes of recovery. ICU admission, hospital length of stay, and postoperative pulmonary complications are listed as secondary outcomes. The registry record lists four outcome measures and zero analyses, but does not post primary or secondary outcome results.

Safety information reports 15 participants at risk in each group, no serious adverse events or deaths in either group, and other adverse events in 2 participants in the dominant-hand group and 0 in the non-dominant-hand group. Further event details are not reported in the registry record.