Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery (NCT01545700), a randomized phase 4 study. The primary outcome is Serum Blood Glucose Concentrations.

2. Clinical Question

In statistical terms, the clinically relevant question is whether glucose concentrations differ between randomized treatment groups at comparable times after surgery, and how precisely any such difference is estimated. The posted results give group means at baseline and selected follow-up times. Their accompanying recalculated contrasts compare each listed group-time mean with the placebo baseline mean of 101.0 mg/dl. They do not directly estimate the randomized treatment contrast at a common follow-up time. That distinction matters: a rise from baseline within a group is not, by itself, evidence that the rise differs from the change in another group. The registry record does not report a sponsor analysis of the primary outcome, so the posted summaries cannot establish the result of a prespecified between-group analysis.

3. Trial Design

The registry record identifies this as a randomized, quadruple-masked, parallel phase 4 trial, with an enrollment of 200. Its status is completed. The sponsor is Endeavor Health. The record lists the start as 2009-09 and primary completion as 2012-11. It describes saline control and dexamethasone at 4 mg or 8 mg, with outcome groupings labelled 0-4 hours and 8-24 hours.

A parallel design assigns participants to a group and compares the groups, rather than crossing each participant through every treatment. Randomization is intended to make treatment groups comparable on average at assignment. Masking is intended to limit the influence of knowledge of group assignment on care or measurement; the specific roles included in the quadruple masking are not reported in the registry record. Further details of the randomization method, allocation concealment, treatment adherence, or masking procedures are not reported in the registry record.

The glucose outcome is described for the per-protocol population. The record gives group sizes for each listed measurement, with counts ranging from 31 to 34. It does not report a participant flow account, reasons for exclusion from the per-protocol population, or the number originally randomized to each group. The outcome timeframe says patients were followed for the duration of hospitalization, for an average of 6 days, while the displayed glucose observations are at baseline and selected hours after intervention.

The registry record does not report the trial's original sample-size justification, planned primary analysis, handling of repeated measurements, interim analyses, or a statistical analysis plan. It also contains no reported analyses for the primary outcome. Consequently, the posted numerical comparisons are recalculations from group summary statistics and should not be mistaken for a reported sponsor model or for the trial's original analysis.

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: A total of 200 patients were enrolled in this clinical trial.

Overall Study

Analysis population for the primary outcome, as defined in the registry: per protocol

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.

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Serum Blood Glucose Concentrations, measured over Patient were followed for the duration of hospitalization, for an average of 6 days.

The primary endpoint is serum blood glucose concentration, measured in mg/dl and summarized as a mean with standard deviation. The registry record describes the outcome as serum blood glucose concentrations and identifies the analysis population as per protocol. The stated follow-up covers the duration of hospitalization, for an average of 6 days. The posted measurements include baseline and selected observations at 1, 2, 3, and 4 hours for the 0-4-hour groups, and at baseline, 8 hours, and 24 hours for the 8-24-hour groups.

Glucose concentration is a continuous measure: each recorded value conveys the level measured, rather than simply whether a person crossed a threshold. It is used to describe the distribution and average level of glucose across participants in a group. Means allow straightforward comparison of group summaries, while standard deviations describe how dispersed individual measurements are around each group mean.

The registry record frames the clinical aim in terms of hyperglycemia, but the primary endpoint is a concentration rather than a reported incidence of hyperglycemia. A definition or threshold for classifying an individual as hyperglycemic is not reported in the registry record. Nor does the record report how the primary endpoint was summarized over the full hospitalization beyond the stated timeframe and the posted selected measurements. Thus the listed values can describe average concentrations at specified times, but do not directly quantify the number or proportion of participants meeting a clinical threshold.

7. Results Posted in the Registry

• Placebo 0-4 Hours-1 Hour: mean 137.00 versus 101.00 on control; difference 36.00 (95% CI 24.90 to 47.10), standardized effect d = 1.57; z-test p = <0.001.
• Placebo 0-4 Hours-2 Hours: mean 140.00 versus 101.00 on control; difference 39.00 (95% CI 28.20 to 49.80), standardized effect d = 1.74; z-test p = <0.001.
• Placebo 0-4 Hours-3 Hours: mean 141.00 versus 101.00 on control; difference 40.00 (95% CI 27.35 to 52.65), standardized effect d = 1.53; z-test p = <0.001.
• Placebo 0-4 Hours-4 Hours: mean 139.00 versus 101.00 on control; difference 38.00 (95% CI 25.35 to 50.65), standardized effect d = 1.45; 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.

Pain Scores

• 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:
  • Dexamethasone 4 mg 0-4 Hours: mean 47.00 versus 50.00 on control; difference -3.00 (95% CI -14.51 to 8.51), standardized effect d = -0.13; z-test p = 0.609.
  • Dexamethasone 8 mg 0-4 Hours: mean 45.00 versus 50.00 on control; difference -5.00 (95% CI -16.08 to 6.08), standardized effect d = -0.22; z-test p = 0.376.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dexamethasone 4 mg 0-4 Hours and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dexamethasone 8 mg 0-4 Hours and the control. The interval gives the range of effects that remain compatible with the data.

Pain Scores is the secondary outcome listed in the registry record. Its posted group means are broadly close across the listed treatment groups, and the two recalculated active-treatment comparisons against the placebo 0-4-hour group have intervals that include zero. This overall pattern differs from the prominent increases in glucose means after baseline, but the measures address different questions: pain scores describe a separate outcome and cannot confirm or refute a glucose effect.

The secondary outcome is recorded as a mean on a 0-100 VAS scale, with standard deviations, during hospitalization for an average of 6 days. The registry record does not report any secondary outcome analyses. The posted recalculations are unadjusted, and their reference is the placebo 0-4-hour group; they are not adjusted estimates from a trial model. As with the primary outcome, a comparison to one reference group does not necessarily represent the intended randomized contrast if the groupings differ by timing.

Secondary findings generally carry less weight than a prespecified primary result because they may involve additional outcomes or comparisons, raising the chance that some apparent differences occur by chance. The registry record does not report a multiplicity strategy or a hierarchy for interpreting secondary outcomes. It also does not report a primary sponsor analysis against which the secondary findings could be formally contextualized. The pain score results should therefore be considered descriptive and exploratory rather than a basis for strong claims about treatment effects.

The secondary outcome does not provide an alternative measure of hyperglycemia, and it cannot resolve the central limitation of the posted primary comparisons: those calculations do not directly contrast active treatment with concurrent saline at matching times. Its role is supplementary, and any interpretation should remain separate from the glucose concentration findings.

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

• Pain Scores

9. Statistical Interpretation

10. Statistical Methods Explained

What is the outcome scale? Serum glucose is a continuous measure, reported as a mean and standard deviation in mg/dl. A mean describes the group average; the standard deviation describes how spread out the participant measurements are around that average. Neither summary alone gives the full distribution. In particular, a mean and standard deviation do not show how many participants exceeded a clinical threshold, and a threshold defining hyperglycemia is not reported in the registry record.

What does a mean difference represent? A mean difference is one group mean minus a reference group mean. A positive estimate means the first listed mean is higher than the reference; a negative estimate means it is lower. In the posted recalculations, the reference is the placebo baseline value of 101.0 mg/dl. Thus, a contrast labelled for a follow-up time compares that group's follow-up mean with the placebo baseline mean. It is not a direct comparison of dexamethasone with placebo at that same follow-up time, nor does it compare the change from baseline between randomized groups.

The posted contrasts are unadjusted calculations from the summary means and standard deviations. An unadjusted comparison does not account for other covariates or for a prespecified model. The registry record does not report a sponsor analysis or adjusted treatment estimate for the primary outcome. It also does not report how the within-participant dependence of repeated glucose measurements was handled in the trial's own analysis. Measurements from the same person are generally related; treating time points as separate independent evidence can fail to represent that relationship. The recalculated group-time contrasts should therefore be read as simple summary comparisons, not as a model of the full longitudinal data.

What do the intervals convey? A confidence interval expresses the range of values reasonably compatible with the estimate under the assumptions of the calculation. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. If an interval includes zero for a mean difference, the data are compatible with no difference as well as with values on either side, under the calculation's assumptions. If it excludes zero, that is evidence of a nonzero contrast against the specified reference, but the reference must be interpreted correctly. Here it remains a contrast with placebo baseline, not necessarily a treatment effect.

Confidence intervals do not account for every source of uncertainty. In particular, they do not correct for choosing among many groups, time points, or outcomes. They also cannot repair a mismatch between the contrast calculated and the clinical question. The registry record gives no multiplicity adjustment or primary-analysis results, so repeated unadjusted p-values and intervals should be interpreted cautiously.

How should p-values be read? A p-value describes how incompatible the observed data are with a specified null hypothesis, assuming the analysis model and its assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The posted p-values correspond to unadjusted contrasts with the listed reference. For example, p < 0.001 indicates that the group mean is statistically distinguishable from the placebo baseline under that calculation, but does not establish a treatment-versus-placebo effect at the same time point.

Why does dispersion matter? Standard deviations describe variation among participants. Greater variation generally makes a group mean less precisely estimated for a given group size. The posted standard deviations vary across groups and time points, so estimates with similar means or sample counts need not have the same precision. The comparison calculations also report pooled standard deviations, which combine group variability for a two-group summary contrast. This pooling is a computational convention and does not establish that a treatment comparison was the trial's prespecified analysis.

What analysis details are absent? The primary outcome is identified as per protocol, but the registry record does not report how that population was defined, how missing measurements were handled, whether any participants were excluded after randomization, or the original statistical plan. It records no reported analyses. The planning illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, but those are assumptions for the posted planning calculations, not reported assumptions for the trial's original design. No interim analyses or sample-size justification are reported in the registry record.

11. Confidence Intervals and Precision

The recalculated intervals quantify uncertainty around unadjusted mean differences, conditional on the comparison and its assumptions. For the 0-4-hour placebo group, the contrast against the placebo baseline is 36.0 mg/dl at 1 hour, with an interval from 24.9 to 47.1; at 2 hours it is 39.0 mg/dl, with an interval from 28.2 to 49.8. The interval widths differ across estimates, reflecting differences in the observed variability and sample summaries. These intervals describe precision for the stated baseline contrasts, not precision for a dexamethasone-versus-saline effect.

Several dexamethasone baseline contrasts have intervals that include zero. For the 4 mg 0-4-hour group, the estimate is 6.0 mg/dl, with an interval from -2.852 to 14.85. For the 8 mg 0-4-hour group, it is 7.0 mg/dl, with an interval from -2.538 to 16.54. The 4 mg 8-24-hour baseline contrast is -3.0 mg/dl, with an interval from -10.49 to 4.494; the 8 mg contrast is -1.0 mg/dl, with an interval from -9.212 to 7.212. Such intervals allow both small positive and negative contrasts and do not establish equivalence.

At follow-up, many intervals for the contrast with placebo baseline lie entirely above zero. That indicates precision about a difference from that baseline reference, but does not resolve whether the active-treatment groups differ from saline at the same time. The posted outcome counts for individual observations range from 31 to 34, and the standard deviations differ across groups. Both the number of observations and their variability contribute to uncertainty.

Precision is not the same as clinical importance. The registry record does not report a threshold for hyperglycemia or a clinically important difference in glucose concentration, so the intervals cannot be judged against either criterion. They also do not incorporate uncertainty from unreported analysis choices or multiplicity. A confidence interval is informative only when its estimate answers the question of interest; these recalculated intervals are most safely read as descriptive, unadjusted group-time contrasts.

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 for 80% power and participants per arm for 90% power; they are not total event counts. The calculations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They use the observed effect as a starting point and include scenarios planning for 100%, 75%, or 50% of that observed effect. The trial's own original design assumptions and sample-size justification are not reported in the registry record.

Power is the probability, under a specified assumed effect and analysis, of detecting that effect at the selected significance level. The 80% column gives an illustrative per-arm sample size associated with an 80% chance of detecting the assumed effect; the 90% column uses a higher target chance and therefore generally calls for more participants per arm. These figures are hypothetical planning calculations based on the posted observed contrasts, not the trial's original design calculations. They are not observed power.

The rows planning for smaller fractions of an observed effect require more participants per arm, because smaller differences are harder to distinguish from random variation. A planning result depends on the effect chosen, variability, allocation, significance level, and calculation assumptions. The posted calculations do not account for all features that might matter in a longitudinal trial, such as correlation among repeated observations, nor do they establish that the corresponding effect is clinically important.

Because the observed contrasts are mainly comparisons with the placebo baseline rather than direct treatment contrasts at matching times, their planning illustrations should not be treated as sample-size recommendations for a definitive dexamethasone-versus-saline comparison. The registry record does not report the original sample-size rationale, so these calculations are context for the posted summary effects only.

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 = 36.000; pooled standard deviation σ = 22.984.
2. n = 2 × (1.96 + 0.842)² × 22.984² / 36.000² = 6.4, rounded up to 7 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 <- 36                      # observed difference in means
sigma <- 22.9839408818753                     # 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(1545700)
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 = 7 (80% power), 9 (90% power)
 75% of observed effect: n per arm = 12 (80% power), 16 (90% power)
 50% of observed effect: n per arm = 26 (80% power), 35 (90% power)
power.t.test: 7.5 
Simulated power at n = 7 per arm: 0.768 (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 multiple glucose measurements across treatment groups and follow-up times, as well as Pain Scores as a secondary outcome. Each separate comparison creates another opportunity for a result to appear statistically notable by chance. When many hypotheses are tested, unadjusted p-values do not control the overall chance of at least one false-positive finding across the full set of tests.

The posted recalculated p-values are unadjusted. A multiplicity adjustment, prespecified testing hierarchy, or strategy distinguishing confirmatory from exploratory comparisons is not reported in the registry record. The record also lists no reported analyses for the primary outcome and no reported analyses for the secondary outcome. Consequently, it is not possible to determine which comparisons, if any, were designated as the primary inferential test or how the trial's investigators intended to account for repeated measurements and multiple comparisons.

The primary outcome population is described as per protocol. The criteria used to define that population, the number excluded from it, and the reasons for exclusion are not reported in the registry record. The record does not describe missing-data methods, imputation, or sensitivity analyses. It is therefore not possible to assess from the posted summaries whether missing measurements could have affected the reported group means or how per-protocol exclusions might relate to outcomes.

The original analysis plan, sample-size justification, and interim-analysis procedures are also not reported in the registry record. These omissions limit assessment of whether the posted comparisons follow prespecified methods or represent selected analyses. They do not prove that particular methods were or were not used; they mean the registry record does not document them. The numerical results should accordingly be read as posted descriptive data and unadjusted recalculations, rather than as a complete account of the trial's confirmatory statistical analysis.

15. Safety Results

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

Other (non-serious) adverse events

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

The registry record lists 0 serious adverse events among 67 participants at risk in the control-saline group and 0 among 128 participants at risk in the dexamethasone group. It also lists 0 other adverse events among 67 at risk in the control group and 0 among 128 at risk in the dexamethasone group. No serious adverse event terms are listed.

These figures are counts reported for the groups and categories recorded in the registry. They do not mean that the risk of an adverse event is zero. When no events are observed, the data still allow for some underlying event risk, particularly when the number of participants observed is limited. The registry record does not give event-specific follow-up duration or further detail on adverse-event collection.

Deaths are not reported in the registry record. The adverse-event figures should be interpreted as a registry summary, not as a complete safety assessment or as proof that an intervention is free of risk. They also do not address glucose concentrations, which are reported separately as the primary outcome.

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

The posted results document higher mean glucose concentrations at selected postoperative times than at baseline in the listed placebo and dexamethasone groups. They also show variation among participants, represented by the reported standard deviations. The recalculated contrasts quantify differences between each listed group-time mean and the placebo baseline mean, with unadjusted intervals and p-values.

Those calculations do not answer the central randomized treatment question directly. A comparison with a common baseline value cannot establish whether dexamethasone groups differ from saline groups at the same time, or whether their changes from baseline differ. The registry record does not report the sponsor's primary analysis, a threshold defining hyperglycemia, or the number of participants who crossed such a threshold. It therefore does not provide a direct estimate of hyperglycemia incidence based on a stated definition.

The results also do not establish that any observed difference is clinically important. Statistical separation from a reference mean is not equivalent to clinical importance, and no clinically meaningful difference threshold is reported in the registry record. Likewise, a p-value does not indicate the probability that an effect is true or quantify the likely benefit or harm.

The record identifies the trial as randomized and quadruple-masked, features that can support an informative comparison when the corresponding analyses are appropriately specified and reported. But the available summary results and recalculations do not supply such a treatment contrast. The appropriate conclusion is limited to describing the reported concentration patterns and their uncertainty. The posted data neither establish nor rule out a treatment effect on glucose relative to saline, and they do not provide a complete assessment of safety or clinical outcomes.

17. Why This Trial Matters Statistically

This trial is statistically instructive because its stated clinical aim concerns hyperglycemia, while its primary outcome is a continuous glucose concentration. These are related but distinct forms of evidence. A concentration summary can show average levels and their variability; an incidence outcome requires a threshold and a count of participants meeting it. The registry record does not report that threshold or an incidence analysis.

It also illustrates why the choice of comparison is as important as the size of a mean difference. The posted recalculations compare observations with placebo baseline. Although many such contrasts are statistically distinguishable from zero, this does not answer whether randomized dexamethasone and saline groups differ at the same follow-up time. A statistically clear contrast can still be misaligned with the treatment question if its reference is not the relevant comparator.

Repeated glucose measurements raise an additional analysis issue: observations from the same participant are related. A full longitudinal analysis can account for that dependence and compare group patterns over time. The registry record does not report the trial's original analysis, so the reader cannot evaluate how that issue was handled in the sponsor's work. The recalculated contrasts are useful descriptive summaries, but they cannot substitute for the missing treatment analysis.

Finally, the planning illustrations show how assumptions about the effect size shape sample-size requirements. They are explicitly based on observed contrasts and do not reveal the original design rationale. Keeping planning calculations distinct from observed evidence, and distinguishing statistical precision from clinical importance, are essential when interpreting registry results.

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 most important trial-specific limitation in the registry record is that the primary outcome is reported as group means and standard deviations, while the stated aim concerns hyperglycemia. A threshold definition and counts of participants meeting it are not reported. The record therefore does not directly report the incidence implied by the clinical aim.

The available recalculated contrasts use the placebo baseline mean as the reference for all groups and times. They do not provide direct dexamethasone-versus-saline contrasts at matching follow-up times or comparisons of change from baseline between randomized groups. This limits what can be inferred about treatment differences from the posted values, even when an individual contrast has a small p-value.

The glucose outcome is described for a per-protocol population, but the definition of that population and details of exclusions are not reported in the registry record. There is no participant flow account, missing-data method, or reported sensitivity analysis. The listed counts differ by group and time point, and the reasons for those differences are not given.

The record does not report a sponsor analysis, the original statistical plan, a sample-size justification, or a multiplicity strategy. It also does not document how repeated measurements were handled. These absences prevent assessment of whether the recalculated summaries match the trial's intended confirmatory analysis. The displayed follow-up times cover selected hours, while follow-up is described as lasting through hospitalization for an average of 6 days; further details on glucose assessment over that period are not reported in the registry record. Finally, the adverse-event summary does not report deaths, and zero recorded events should not be interpreted as proof of no risk.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery — NCT01545700.
• Registry record last updated 2019-09-30; status last verified 2019-09.
• Results first posted 2013-01-15.
• 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

NCT01545700 is a completed, randomized, quadruple-masked, parallel phase 4 trial sponsored by Endeavor Health, with enrollment of 200. The interventions were saline, dexamethasone 4 mg, and dexamethasone 8 mg, with outcome groups labelled 0-4 hours and 8-24 hours.

The primary outcome was serum blood glucose concentration in mg/dl, summarized as mean and standard deviation in a per-protocol population. Posted means rose from baseline at selected follow-up times across placebo and dexamethasone groups. Recalculated unadjusted contrasts use placebo baseline as the reference and do not constitute direct randomized comparisons at matching times. The registry record reports no primary or secondary analyses and does not report an incidence threshold for hyperglycemia, the original statistical plan, or missing-data procedures.

Pain Scores are listed as a secondary outcome. The adverse-event summary records no serious or other events in the stated groups; deaths are not reported in the registry record. The available results are descriptive and do not establish a treatment effect relative to saline.