Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery (NCT03112993), a randomized phase 4 study. The primary outcome is Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade.

2. Clinical Question

The clinical question concerns the speed of reversal after muscle relaxants had been used to support surgical exposure. The registry description explains that surgery was performed with patients prone, and that reversal took place at the end of surgery after return to the supine position. The endpoint therefore focuses on a measured physiological recovery threshold rather than on a broad assessment of recovery or later functioning.

The study also asked about the time from reversal to tracheal extubation and length of stay in the post-anesthesia care unit (PACU). These secondary outcomes address subsequent steps in the perioperative course, but they are not the same measure as the primary neuromuscular recovery endpoint. The registry lists safety as an area of investigation as well. The comparison is between the two assigned reversal regimens in this specific surgical and age group; it does not directly answer questions about other operations, other populations, or other dosing approaches.

3. Trial Design

The registry describes a prospective, randomized, double-blind clinical trial with a parallel-group design. It lists phase 4 and a completed status. Total enrollment was 40, with 19 participants in the sugammadex group and 21 in the neostigmine group for the primary outcome. The recorded dates are a study start of 2017-05-30 and a primary completion date of 2018-08-13.

Participants were assigned to one of two reversal regimens at the end of surgery. The sugammadex group received 2 mg/kg intravenously once, with dose based on actual body weight. The neostigmine group received 50 micrograms/kg intravenously once, capped at 5 mg, along with glycopyrrolate at 10 micrograms/kg, capped at 1 mg. Its dose was also based on actual body weight. The registry records quadruple masking. It does not identify which roles or groups were masked, so the precise masking arrangements are not reported in the registry record.

The parallel design means that the posted group summaries compare different participants assigned to each regimen, rather than repeated observations of every participant under both regimens. Random allocation is intended, in general, to support a fair comparison by distributing participant characteristics across groups on average. In a study enrolling 40 participants, chance imbalances can still occur, and the record does not provide baseline characteristics or an account of allocation implementation.

The registry identifies the primary endpoint as the time, in minutes, to neuromuscular recovery on Day 1. It lists two secondary outcomes: time from neuromuscular reversal to tracheal extubation and length of stay in PACU. Outcome assessments are available for the two groups, but the trial's original design assumptions, sample-size justification, detailed statistical analysis plan, eligibility criteria beyond the described population, and participant flow are not reported in the registry record. The record also does not report whether any interim analyses were planned or conducted.

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.

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 Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade, measured over Day 1.

The primary endpoint is time in minutes from moderate neuromuscular blockade to recovery, defined as a T4:T1 ratio ≥ 0.9 measured with a TOF-Watch SX. The assessment is listed for Day 1. The posted outcome is summarized as a mean with a standard deviation for each group. A mean gives the average observed time, while the standard deviation describes how spread out individual times are around that average.

This endpoint provides a defined measurement of neuromuscular recovery. Using a specified ratio threshold makes the outcome more concrete than an unstructured judgment that recovery is complete. It also focuses the comparison on the process the study set out to examine: the time needed to reach the stated recovery criterion after reversal of the blockade. The clinical description places the measurement in the context of surgery requiring muscle relaxation, followed by reversal at the end of the operation.

The endpoint is not itself a measure of every aspect of postoperative recovery, nor does it directly establish what happened to later clinical outcomes. The time to tracheal extubation and PACU length of stay were separately listed as secondary outcomes. Those outcomes may reflect additional clinical and operational steps beyond reaching the neuromuscular ratio threshold. The registry record does not report further details on measurement timing, assessor procedures, missing endpoint observations, or how repeated or technically unavailable measurements were handled.

7. Results Posted in the Registry

• Neostigmine Group: mean 26.29 versus 3.90 on control; difference 22.39 (95% CI 14.84 to 29.94), standardized effect d = 1.75; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Difference in Time From Neuromuscular Reversal to Tracheal Extubation

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Neostigmine Group: mean 23.60 versus 5.30 on control; difference 18.30 (95% CI 10.22 to 26.38), standardized effect d = 1.34; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Neostigmine Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Difference in Length of Stay in PACU

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Neostigmine Group: mean 85.30 versus 81.40 on control; difference 3.90 (95% CI -10.74 to 18.54), standardized effect d = 0.16; z-test p = 0.602.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Neostigmine Group and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes extend the primary question from measured neuromuscular recovery to subsequent perioperative events. Across the outcomes, the broad pattern is that the comparison for time to tracheal extubation points in the same direction as the primary recovery-time comparison, while the length-of-stay measure in PACU is less clearly separated between groups. This distinction is important: a pattern of faster measured recovery does not require every downstream time measure to show an equally clear contrast.

These outcomes are related but not interchangeable. Extubation follows reversal and can depend on more than the time to reach the neuromuscular recovery threshold. PACU length of stay is a broader process measure and may reflect clinical and operational factors not captured by the primary endpoint. The posted results therefore speak to separate stages of care, not a single composite measure of postoperative recovery. The registry does not report further explanatory analyses that would identify why the results differ across these outcomes.

The secondary results carry less inferential weight than the primary result because they are secondary measures, and the registry record does not report a multiplicity strategy or a prespecified hierarchy for interpreting them. When several outcomes are examined, the chance of finding an apparently notable pattern among them can increase unless the analysis plan addresses that issue. No adjustment should be assumed. The record lists no reported analyses for these secondary outcomes, so their posted comparisons should be treated as unadjusted descriptions rather than as a fully documented confirmatory analysis.

The overall pattern is useful for understanding how the primary measurement relates to later steps, but it does not establish that changes in one endpoint caused changes in another. Nor does a less distinct secondary comparison contradict the primary result: the measures capture different events and have different variability. The registry record does not report a formal analysis of relationships among endpoints or a combined outcome.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Difference in Time From Neuromuscular Reversal to Tracheal Extubation
• Difference in Length of Stay in PACU

9. Statistical Interpretation

10. Statistical Methods Explained

The posted outcomes are continuous measurements: times expressed in minutes. For each group, the registry gives a sample size, a mean, and a standard deviation. For the primary measure, the group means are 3.9 and 26.29 minutes, and the corresponding standard deviations are 2.2 and 17.51 minutes. For continuous outcomes, comparing group means is one way to summarize a difference in average observed time. It is not a description of every participant's outcome, and it can be affected by skewness or unusually long observations.

What does the mean difference represent?

The posted primary mean difference is 22.39 minutes, calculated in the comparison with the neostigmine group mean set against the sugammadex group mean. Positive values therefore indicate a higher mean in the neostigmine group under that stated ordering. The mean difference is measured in the same units as the outcome, which makes its scale directly interpretable as minutes. The record presents the estimate and interval, but does not report a full statistical analysis plan or all details of the test used to obtain the inferential results.

What does the standard deviation tell us?

Standard deviation describes dispersion among participant measurements within a group; it is not the uncertainty interval around the group mean. A large standard deviation indicates that observations are more spread out relative to the average. Here, the primary outcome's standard deviation is much larger in the neostigmine group than in the sugammadex group. This difference in spread matters when interpreting mean-based summaries. If a time outcome has a long right tail, a small number of long times can influence the mean and standard deviation. The registry record does not provide distribution plots, medians, quantiles, or individual measurements that would allow the shape of the observed times to be assessed.

General statistical explanation: when outcomes are highly skewed or have unequal variability, model assumptions for a simple mean comparison may not describe the data well. Over-dispersion means the observed variation is greater than a model expects; accounting for it can make uncertainty estimates more realistic. This is a general consideration for continuous outcomes, not a claim that a particular model or adjustment was used in this trial. The analysis method and diagnostic checks are not reported in the registry record.

How should the confidence interval be read?

A confidence interval expresses uncertainty around an estimated effect. In general, it gives a range of values that would be compatible with the data under the procedure and assumptions used to construct it. A narrower interval indicates greater precision than a wider interval on the same scale. The primary interval runs from 14.84 to 29.94 minutes around the posted mean difference of 22.39 minutes. It describes uncertainty in the estimated group-average contrast; it is not a range containing a specified proportion of individual participants' recovery times. The registry record does not state the confidence level or the precise interval method.

The posted unadjusted p-value for the primary comparison is <0.001. In general, a p-value measures how unusual data at least as incompatible with a null hypothesis as the observed data would be if that null hypothesis and the test assumptions held. It is not a measure of the probability that the null hypothesis is correct, nor does it indicate the magnitude of an effect. A small p-value can accompany estimates with different degrees of precision, so the estimate and interval remain important. The record does not identify the complete testing procedure or whether the p-value was generated under a prespecified analysis.

What does randomization contribute?

Random assignment is a design method intended to reduce systematic differences between treatment groups at the point of assignment. In general, it supports a causal comparison when assignment is implemented as planned, outcomes are observed consistently, and the analysis appropriately follows the design. Randomization does not guarantee that groups will be identical, especially in a small trial. The registry records random allocation but does not report the sequence-generation method, concealment procedures, baseline balance, or a detailed participant-flow account. Those implementation details cannot be evaluated from the record.

The study is described as double-blind in its official title and quadruple-masked in its design record. The record does not specify the people or roles covered by either description. Masking can, in general, reduce the potential for expectations to affect care, measurement, or interpretation, but the degree to which it did so cannot be assessed without those details. No conclusions about the success of masking are reported.

What can be inferred from the posted comparison?

The comparison is a group-level estimate for the participants with primary outcome summaries. It does not supply a covariate-adjusted estimate, a per-protocol comparison, or a description of an intention-to-treat analysis. The analysis population is not reported in the registry record. Although the primary group counts total 40, the record does not provide enough information to determine whether all randomized participants contributed to every outcome or how any missing measurements were handled. These are relevant distinctions because exclusions and missing data can affect the population represented by an estimate.

The displayed comparison is unadjusted. That means readers should not assume that it accounts for baseline factors or other outcomes. Unadjusted results can be informative, particularly in a randomized design, but interpretation still depends on how randomization, outcome measurement, and missing observations were handled. The record identifies zero reported analyses, so a fuller account of model specification, assumptions, diagnostic checks, and analysis populations is not available. General statistical principles can explain what the summaries mean, but they cannot fill in unreported trial procedures.

11. Confidence Intervals and Precision

The primary mean difference is 22.39 minutes, and its confidence interval extends from 14.84 to 29.94 minutes. The interval is entirely above zero, so the posted range of plausible values under the reported procedure does not include no mean difference. The values within the interval remain meaningfully spread, however: the result is not an exact estimate of the underlying group contrast. The registry record does not state the confidence level or the method used to construct the interval, which limits a more specific interpretation of its coverage.

Precision is also reflected in the group summaries. The sugammadex group has 19 participants and a standard deviation of 2.2 minutes; the neostigmine group has 21 participants and a standard deviation of 17.51 minutes. These values show both the limited group sizes and the difference in observed variability. The wider spread in one group is relevant to uncertainty, and the mean alone cannot convey the full distribution of individual times. No participant-level data or distribution summaries beyond the means and standard deviations are reported.

A confidence interval concerns uncertainty in the estimated average contrast, not the range of outcomes an individual participant might experience. It also does not account for every possible source of uncertainty, such as unreported missing-data decisions or deviations from the intended design. The estimate is relatively clear in direction within its posted interval, but the small trial and incomplete reporting of analysis details constrain how broadly to generalize it. Precision should therefore be considered together with the design, population, endpoint definition, and limits of the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not a total sample size and not total events. The underlying illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers detecting a stated fraction of the observed effect, with rows for 100%, 75%, and 50% of that effect. These are planning assumptions for an illustration based on the observed comparison; the trial's own original sample-size assumptions and justification are not reported in the registry record.

The column for participants per arm for 80% power represents the modeled group size that would give an 80% chance of detecting the selected effect under those assumptions, if the assumed effect and model are appropriate. The 90% power column uses a higher target chance of detecting that effect and therefore generally calls for more participants. These percentages describe long-run operating characteristics under a specified model, not the probability that the trial's result is correct.

Smaller target effects require more participants because a modest difference is harder to distinguish from random variation than a larger one. For example, planning for 50% of the observed primary effect calls for 21 participants per arm for 80% power, compared with 6 participants per arm for 100% of the observed effect. Such calculations are sensitive to the assumed effect size and variability; using an effect estimated from a small trial can make the illustration uncertain. This is not observed power. It is a forward-looking planning calculation under stated assumptions, not a measure of the trial's success after results are known.

The calculations do not establish that the completed trial was designed around these inputs, and they should not be read as a recommendation for a future study without additional design information. The registry record does not report the original protocol's target enrollment, allowance for missing observations, or sample-size rationale.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 22.390; pooled standard deviation σ = 12.793.
2. n = 2 × (1.96 + 0.842)² × 12.793² / 22.390² = 5.1, rounded up to 6 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 22.39                      # observed difference in means
sigma <- 12.7930100157531                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3112993)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 6 (80% power), 7 (90% power)
 75% of observed effect: n per arm = 10 (80% power), 13 (90% power)
 50% of observed effect: n per arm = 21 (80% power), 28 (90% power)
power.t.test: 6.2 
Simulated power at n = 6 per arm: 0.778 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary endpoint and two secondary outcomes, but does not report a multiplicity strategy. Multiplicity refers, in general, to the increased chance of at least one false-positive finding when several statistical hypotheses are tested. A prespecified approach might control that risk, define a testing order, or distinguish confirmatory from exploratory comparisons. None of those procedures is described in the registry record, so no adjustment or hierarchy should be assumed. The posted secondary comparisons are unadjusted.

The registry identifies zero reported analyses. It therefore does not give a complete account of the statistical procedures used, including whether comparisons were prespecified, what test produced the p-values, how confidence intervals were constructed, or whether any covariate adjustment was planned. The record also does not report interim analyses. These omissions do not show that such procedures were absent; they mean their status is not reported in the registry record.

Missing-data handling is also not reported. The record provides group counts for the outcomes, but does not describe whether all randomized participants were assessed at each time point, whether any measurements were unavailable, or how missing values were treated. The primary endpoint's listed group sizes sum to the recorded enrollment, but that fact alone does not establish the analysis population or resolve missing-data procedures for every outcome.

The analysis population is not reported in the registry record. It is not stated whether results followed an intention-to-treat approach, a per-protocol approach, or another definition. The participant flow from randomization through outcome assessment, reasons for any exclusions, and deviations from assigned regimens are also not described. These details matter because the groups included in an analysis can differ from the groups originally randomized, and analysis choices can affect interpretation.

These reporting gaps limit assessment of the robustness and confirmatory status of the results. They should be distinguished from evidence that an analysis was mishandled: the record is incomplete on these points, rather than documenting a specific problem. A protocol or fuller report would be needed to assess the planned testing strategy, missing-data approach, analysis populations, and any interim monitoring.

15. 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 serious adverse event terms

Serious events with the highest arm-level rate: prolonged hospitalization (10.5%), blood transfusion (9.5%), icu admission (4.8%).

The registry safety summaries use the participants at risk in each group as denominators. Serious adverse events affected 2 of 19 participants in the sugammadex group and 4 of 21 in the neostigmine group. Other adverse events affected 0 of 19 and 0 of 21, respectively. Deaths were recorded as 0 in each group. These are counts for the groups and should be read as descriptive figures, not as proof that one regimen caused or prevented an event.

The registry also lists prolonged hospitalization at 10.5%, blood transfusion at 9.5%, and ICU admission at 4.8% among the top serious adverse event terms. The record does not provide an arm attribution for these listed percentages in the posted term summary. It is therefore not possible to assign those percentages to a particular group from the available record. The terms may describe events recorded during the trial; their listing alone does not establish relatedness to study treatment.

Safety interpretation is limited by the small group sizes and the absence of detailed event descriptions, timing, severity, relatedness assessments, or an account of how events were collected. Zero recorded events in the other-adverse-event and death categories does not establish absence of risk. These summaries describe what was recorded in this trial and are not a complete assessment of safety across broader populations.

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

The primary result describes a difference in the average time to a defined neuromuscular recovery threshold between the two randomized groups. The posted estimate is 22.39 minutes, with a confidence interval from 14.84 to 29.94 minutes and an unadjusted p-value of <0.001. The group means and observed variability provide context for that contrast. Together, these results show a clear separation in the recorded average recovery times in this enrolled sample, while the confidence interval and group summaries convey that the estimate is not exact and that participant times varied.

This does not mean that every participant in one group recovered sooner than every participant in the other group. The record provides aggregate means and standard deviations, not individual outcomes. Nor does the primary endpoint encompass every aspect of anesthesia recovery, postoperative care, or safety. The secondary measures concern extubation timing and PACU stay, and their pattern is not identical to the primary comparison.

The results also do not establish that the same estimates would apply to all geriatric patients, other types of surgery, or different clinical settings. The trial enrolled 40 participants undergoing spine surgery, and the registry does not provide detailed eligibility criteria or demographic characteristics beyond the age description. The record does not report the analysis populations, missing-data handling, covariate adjustment, multiplicity procedures, or the original sample-size rationale. Those gaps limit assessment of generalizability and the full analytic context.

Statistical evidence about a group difference is not itself a treatment recommendation. The registry findings should be understood as trial-specific estimates for the measured outcomes, not as a complete evaluation of benefit, harm, or clinical decision-making. The safety summaries are limited counts and do not establish that adverse events were or were not caused by either regimen. A broader judgment would require evidence beyond the posted results and careful consideration of the intended clinical context.

17. Why This Trial Matters Statistically

This trial illustrates how a clinical question can be translated into a measurable continuous endpoint. Rather than relying on a general impression of recovery, the primary outcome defines recovery using a T4:T1 ratio ≥ 0.9 and measures time in minutes. That operational definition supports a direct group comparison and helps readers distinguish the physiological endpoint from later events such as extubation or discharge from PACU.

It also shows why an average difference should be read with its spread and interval. The posted means are separated, but variability differs between groups, especially for the neostigmine group. A mean communicates the center of the observed data, while the standard deviation and confidence interval contribute different information: one describes participant-level spread, and the other expresses uncertainty around the estimated contrast. These measures should not be treated as interchangeable.

The record highlights the importance of complete statistical reporting. Randomization and masking are identified, but details of allocation, analysis populations, missing observations, the statistical plan, and multiplicity are not reported. Those details help readers judge how closely the posted comparison follows the intended design and how much confidence to place in secondary findings. A prominent primary result does not eliminate the need for those details.

Finally, the case demonstrates the difference between an observed trial result and a planning illustration. Calculations based on an observed effect can show how sample requirements change when targeting smaller effects, but they do not reveal the assumptions used to design the completed study and do not measure its observed power. Keeping the clinical endpoint, uncertainty, design, safety counts, and reporting gaps distinct leads to a more disciplined reading of a small randomized trial.

18. 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 trial enrolled 40 participants, so group-level estimates arise from relatively small groups. The registry does not report detailed baseline characteristics, making it difficult to assess how the groups compared on participant features that might be relevant to recovery times. Randomization is recorded, but the allocation method and concealment procedures are not reported in the registry record.

The primary outcome is summarized with means and standard deviations. The group standard deviations differ substantially, and the record does not provide distribution plots, medians, quantiles, or individual measurements. That limits assessment of skewness, outlying times, and whether the mean adequately characterizes the observed times. The interval method and confidence level are also not reported.

Details needed to assess the analysis are missing: the statistical analysis plan, analysis populations, missing-data procedures, protocol deviations, and any covariate adjustment are not reported in the registry record. The record lists no reported analyses, and it does not describe multiplicity handling for the secondary outcomes. The original sample-size justification and interim analysis plans are likewise not reported.

The registry describes the study as double-blind in its official title and quadruple-masked in its design information, but it does not specify who was masked or how masking was maintained. It also does not provide detailed safety-event descriptions, attribution, timing, or relatedness. Finally, the findings concern geriatric patients undergoing spine surgery as described in the record. Eligibility details and participant characteristics are not reported, limiting assessment of how well the results apply to other surgical populations or settings.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery — NCT03112993.
• Registry record last updated 2022-04-01; status last verified 2022-03.
• Results first posted 2020-02-10.
• 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.

22. Record Summary

NCT03112993 is a completed phase 4 randomized, parallel-group trial comparing sugammadex with neostigmine plus glycopyrrolate for reversal of neuromuscular blockade in geriatric patients undergoing spine surgery. The registry records quadruple masking and total enrollment of 40. The primary Day 1 endpoint was time in minutes to a T4:T1 ratio ≥ 0.9.

The posted primary mean difference is 22.39 minutes, with a confidence interval from 14.84 to 29.94 minutes and an unadjusted p-value of <0.001. Secondary outcomes address time to tracheal extubation and PACU length of stay. Serious adverse events affected 2 of 19 participants in the sugammadex group and 4 of 21 in the neostigmine group; deaths were recorded as 0 in both groups.

Important details—including the original sample-size rationale, analysis populations, missing-data procedures, statistical plan, and multiplicity strategy—are not reported in the registry record. The posted estimates should therefore be interpreted with the trial's small enrollment and reporting limits in mind.