Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia (NCT06482125), a randomized na study. The primary outcome is Emergence Agitation.

2. Clinical Question

The question concerns a score measured repeatedly during emergence and recovery, rather than a single measurement at a fixed time. The registry describes assessments starting at extubation and continuing every 15 minutes until the patient was completely awake in the recovery room. It says the values were summed and an average reported, although that wording does not fully clarify how the score was aggregated.

The trial is listed as randomized, parallel-group, and single-masked. Enrollment was 121. The registry record does not specify who was masked, how randomization was implemented, or whether the primary comparison was intended to use the continuous score, a categorized score, or both. Those details matter when interpreting the reported mean summaries alongside the separate odds-ratio analysis.

3. Trial Design

The registry describes a completed, randomized, single-masked, parallel-group trial comparing two anesthetic maintenance approaches in pediatric participants. Enrollment was 121. The record lists 62.0 participants in the inhalation sevoflurane arm and 59.0 in the total intravenous dexmedetomidine arm. The trial is marked completed; its start date is 2024-07-31 and its primary completion date is 2024-12-31.

In the inhalation sevoflurane group, sevoflurane at 2-3 Vol% was used as the sole anesthetic maintenance agent throughout the surgical procedure. In the dexmedetomidine group, the arm description specifies total intravenous dexmedetomidine as the sole maintenance agent, with 1.5ug/kg administered within 10 minutes and 1.5ug/kg/hour used for maintenance throughout the procedure. The record does not describe other aspects of anesthesia or perioperative care, so the comparison should be understood as the two posted maintenance strategies rather than a fully detailed account of all care.

The primary outcome is Emergence Agitation, described as a mean score on a scale and reported with standard deviations. Assessments were made from extubation at 15-minute intervals until complete awakening in the recovery room. The registry also lists Time to Extubation (Minutes) and Time to Full Recovery as secondary outcomes. It lists five outcome measures and five analyses, but the record does not explain how these counts map to each outcome or which analyses were prespecified.

Further design details—including the masking role, allocation concealment, eligibility criteria, and the rationale for the planned enrollment—are not reported in the registry record. The trial is listed under the condition Emergence Delirium and sponsored by Pelita Harapan University.

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

Analysis population for the primary outcome, as defined in the registry: Scale of 1.0 - 2.9 indicates no emergence agitation, a scale of 3.0 - 5.0 indicates emergence agitation

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 Emergence Agitation, measured over Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported..

The primary endpoint is Emergence Agitation measured using the Cravero scale. The registry describes scores from 1 to 5: 1 indicates an obtunded state with no response to stimulation; 2 indicates asleep but responsive to movement or stimuli; 3 indicates awake and responsive; 4 indicates crying; and 5 indicates thrashing behavior requiring restraint. The stated population description classifies scores from 1.0 to 2.9 as no emergence agitation and scores from 3.0 to 5.0 as emergence agitation. A separate description gives the upper no-agitation value as 2.9 and the lower agitation value as 3.10, so the record’s descriptions of the boundary are not fully consistent.

Assessment begins at extubation and is repeated every 15 minutes until the patient is completely awake in the recovery room. The registry says the total score is summed and an average is reported, and identifies the endpoint statistic as a mean with standard deviation. A repeated score can describe the level of agitation over the observed recovery period, rather than only at one moment. However, the exact aggregation procedure and handling of different numbers of observations are not reported in the registry record.

The posted mean is 3.9 with standard deviation 0.9 for sevoflurane and 2.5 with standard deviation 0.6 for dexmedetomidine. The score is a measure of observed behavior during emergence; it is not, by itself, a measure of every aspect of recovery or a direct explanation of why a participant behaved in a particular way.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What do the mean and standard deviation describe?

A mean is the arithmetic average of the measured scores in a group. Here, the posted means are 3.9 for inhalation sevoflurane and 2.5 for total intravenous dexmedetomidine. A standard deviation describes the spread of observations around a group mean: the posted values are 0.9 and 0.6, respectively. It is not a confidence interval, and it does not say how precisely the mean itself has been estimated. The record reports no confidence intervals for the means.

The outcome is described as a continuous score for analysis, although the underlying scale has a limited set of numeric values and the registry also describes categories for agitation. Treating scores as a mean retains information about levels across the scale, while categorizing scores answers a different question about how many observations fall on either side of a threshold. The registry’s reported mean summaries and odds-ratio analysis therefore need not represent the same estimand—the specific quantity a statistical analysis is intended to estimate.

What does the reported confidence interval mean?

The 95% confidence interval for the reported odds ratio extends from 14.098 to 118.972. In general, a confidence interval expresses the uncertainty around an estimate using a procedure that, under its assumptions, would capture the underlying parameter at the stated rate over repeated studies. It is not a range containing 95% of participant outcomes, nor does it guarantee that the true value lies within this particular interval. The interval’s width signals uncertainty about the size of the odds ratio. Interpretation also depends on knowing which group was the reference and how the outcome was coded, details not reported in the registry record.

Why are the mean results and odds ratio not interchangeable?

A mean comparison concerns the average numeric score. An odds ratio concerns the odds of a defined categorical outcome in one group relative to another. A categorical odds ratio requires a clear definition of the event, group orientation, and the counts or model information used to estimate it. Those details are absent from the registry record. The posted means and standard deviations alone do not provide the event counts needed to verify the stated odds ratio. The record also does not report a direct inferential test or confidence interval for the difference between the means.

The reported method is “Chi-squared, Corrected.” In general, a chi-squared procedure assesses whether categorical outcomes and group membership are associated; a correction may adjust the test’s calculation in specified circumstances. The registry does not identify the correction or explain the categories used, so it is not possible to assess those implementation details. Nor can the stated analysis be assumed to be a test of the continuous mean endpoint.

How should the p-value be read?

The registry reports p = 0.001 for the odds-ratio analysis. In general, a p-value describes how unusual data at least as incompatible with a null hypothesis would be if that null hypothesis and the model assumptions were true. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. Because the outcome definition and odds-ratio orientation are not described, the p-value cannot resolve the uncertainty about what comparison was conducted.

Why does over-dispersion matter in general?

Over-dispersion occurs when the variability in data is greater than a statistical model expects. When that occurs, a model that assumes less variability can understate uncertainty and produce intervals or tests that are too optimistic. This is a general statistical consideration, not a reported feature of this trial. The registry record does not say that an over-dispersion assessment or correction was performed, and the posted summaries do not establish whether over-dispersion is present.

What can be learned from the sample-size illustrations?

Planning illustrations based on an observed effect can show how a hypothetical future study’s required enrollment changes when the effect to detect is set at a fraction of the observed effect. They are not the trial’s own sample-size justification and are not observed power. General planning calculations depend on assumptions about the significance level, allocation, approximation, and target effect. The record describes assumptions including a two-sided significance level of 0.05, equal allocation, and a normal approximation, but does not report the trial’s original sample-size rationale. Such illustrations cannot establish whether the completed trial was adequately planned or whether its result is reproducible.

For this continuous endpoint, the record indicates that values are missing or not estimable for a two-arm recalculation. Consequently, no independent unadjusted comparison of the posted arm summaries is available from the reported analysis output. This limitation is separate from the descriptive means and standard deviations, which remain useful for describing the groups.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Inhalation Sevoflurane")
n   <- c(62)
m   <- c(3.9)
sp  <- c(0.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Inhalation Sevoflurane  62  3.900  0.900  3.671  4.129

11. Analyses Reported by the Sponsor

The registry reports the trial’s own inferential analysis as a corrected chi-squared comparison, with an odds ratio of 40.955, a 95% confidence interval from 14.098 to 118.972, and p = 0.001. It also reports group means and standard deviations for the continuous Emergence Agitation score. These are different forms of result: an odds ratio concerns a categorical outcome, whereas the means summarize numeric scores.

An unadjusted recalculation of the two-arm comparison is not estimable from the posted information for this continuous endpoint. The record does not provide the details needed to connect the categorical odds ratio to the continuous summaries, including its event definition and orientation. Accordingly, no recalculated test or estimate should be substituted for the reported analysis, and the reported odds ratio should not be presented as a comparison of means.

The registry does not flag a discrepancy between its own analysis and a recalculation. That absence does not remove the interpretive gap: the reported analysis remains the only listed inferential result, but its endpoint coding and direction are not explained. The arm summaries can be described on their own terms without treating them as verification of the odds ratio.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and five analyses, and identifies two secondary outcomes: Time to Extubation (Minutes) and Time to Full Recovery. It does not explain how the five measures and five analyses correspond to one another, which outcomes were prespecified as primary or secondary beyond the listed labels, or whether any analyses were exploratory. The record also does not report a statistical plan describing how multiple comparisons were handled.

Multiplicity is a general concern when several outcomes or analyses are examined. Each additional test can create another opportunity for a result to appear unusual by chance. Statistical approaches can account for that issue, but the registry record does not state that an adjustment was planned or used. The reported p = 0.001 should therefore be read as the p-value for the stated analysis, not as evidence that any unreported multiplicity procedure was applied.

The record does not report missing-data counts for the primary outcome, reasons for missing observations, or the method used to handle missing measurements. Since the endpoint is assessed repeatedly until complete awakening, the number and timing of measurements could vary between participants; how such variation was handled is not reported. This does not establish that data were missing, only that the registry record does not document their completeness or handling.

The analysis population is also not described. The record does not state whether the primary analysis included all randomized participants, only participants who received the assigned maintenance anesthetic, or another population. It does not report exclusions from analysis or deviations from assigned treatment. These omissions limit assessment of how closely the analysis follows the randomized comparison.

The record gives no account of interim analyses, stopping rules, or the detailed statistical plan. Those procedures should not be inferred from the completed status or from the reported p-value. The available information supports a description of the posted outcomes and analysis, but not a full audit of prespecification, missingness, or multiplicity control.

13. 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.

The registry reports zero serious adverse events among 62 participants at risk in the inhalation sevoflurane group and among 59 participants at risk in the intravenous dexmedetomidine group. It also reports zero other adverse events in each group and zero deaths in either group. No serious adverse-event terms are listed.

These figures describe the adverse events recorded in the registry for the trial. A count of zero means that no events in the listed category were reported for the at-risk group; it does not establish that an event is impossible or that the treatment has no safety risks. The record does not provide further detail about how adverse events were defined, collected, or monitored, or the observation period for safety outcomes.

With no reported events in either group, these counts do not provide a comparative estimate of relative risk. They also cannot establish equivalence in safety between the groups. The number of participants and the absence of event counts should be considered together with the limited information on event ascertainment. The registry’s zero counts are not a substitute for a complete account of safety monitoring or all possible harms.

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

The registry’s descriptive primary-outcome results show a mean Cravero score of 3.9 with standard deviation 0.9 for inhalation sevoflurane and a mean of 2.5 with standard deviation 0.6 for total intravenous dexmedetomidine. The group averages lie in different ranges under the registry’s stated population classification. This is a description of average measured scores during emergence and recovery, not a participant-by-participant classification or a direct measure of every aspect of recovery.

The registry also reports an odds ratio of 40.955, with a 95% confidence interval from 14.098 to 118.972 and p = 0.001, from a corrected chi-squared analysis. Because the record does not state the categorical event definition or odds-ratio orientation, those figures cannot be confidently translated into a direction of effect or linked to the continuous mean summaries. The record does not give an inferential comparison of the means that can be independently recalculated from the posted details.

The randomized parallel-group design provides a comparison between the two listed anesthetic maintenance strategies within the enrolled trial. However, the registry does not describe important details such as the analysis population, missing-data handling, masking role, or full statistical plan. These gaps restrict how completely the posted results can be evaluated.

The result does not establish that one approach works or does not work, nor does it establish that the result applies to all pediatric participants, surgeries, or care settings. The group summaries and reported analysis should be interpreted as findings recorded for this completed trial. They do not by themselves answer broader questions about benefit, risk, or implementation.

15. Why This Trial Matters Statistically

This trial is statistically interesting because its primary endpoint is presented as a continuous mean score, while the registry’s listed inferential analysis is an odds ratio from a corrected chi-squared method. Those statistics answer different questions. The mean and standard deviation describe the level and spread of numeric scores; an odds ratio requires a defined categorical event. Without the event definition and direction of comparison, readers cannot directly reconcile the inferential result with the descriptive endpoint.

The repeated assessment schedule also matters. The Cravero scale was assessed at extubation and every 15 minutes until complete awakening. A mean across a changing recovery period can depend on how repeated observations are summarized and how participants with different observation patterns are handled. The registry gives a broad description of summing and averaging values but does not fully detail the aggregation or missing-measurement procedures. That makes the endpoint’s construction an important part of interpreting the reported group means.

The posted group summaries offer a readable description of the observed scores, while the categorical analysis reports a confidence interval and p-value. Yet the available record does not supply a directly recalculable inferential comparison for the continuous endpoint. This illustrates why clear reporting of the estimand, outcome coding, analysis population, and statistical method is essential: readers need to know which quantity an estimate represents before interpreting its size or direction.

The record also lists multiple outcome measures and analyses without documenting any multiplicity approach. That information is relevant when interpreting a reported p-value among several possible analyses. Taken together, the trial highlights the value of distinguishing descriptive evidence from inferential evidence and of reporting enough methodological detail for each to be understood on its own terms.

16. 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 trial-specific reporting gaps limit interpretation. The registry does not explain how participants were randomized, who was masked, or whether allocation was concealed. It does not provide eligibility criteria or participant characteristics beyond identifying a pediatric population. These omissions make it difficult to assess the enrolled population and the conduct of the comparison.

The endpoint description contains an ambiguity in its category thresholds: one statement places no agitation through 2.9 and agitation beginning at 3.10, while another describes agitation from 3.0 to 5.0. The record does not explain this difference. It also describes the primary endpoint as the average of repeated scores, but does not give a sufficiently detailed account of how those scores were combined or how differing assessment patterns were handled.

The arm summaries are available as means and standard deviations, but the registry does not report confidence intervals for the means or a directly interpretable inferential comparison of them. The separate odds ratio is not accompanied by the categorical event definition or direction needed to connect it to the continuous endpoint. The posted information does not permit an unadjusted recalculation of the two-arm continuous comparison.

Other limitations include the absence of reported detail on the analysis population, exclusions, missing data, multiplicity, interim analyses, and the original sample-size justification. The registry does not report the reasons for missing observations or whether any were present. These are limitations of the available record, not evidence that a particular problem occurred. Safety counts are also limited to the reported event totals and lack further information on definitions and ascertainment.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia — NCT06482125.
• Registry record last updated 2025-05-28; status last verified 2025-05.
• Results first posted 2025-05-28.
• 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.

20. Record Summary

NCT06482125 is a completed randomized, single-masked, parallel-group trial sponsored by Pelita Harapan University. It enrolled 121 participants and compared inhalation sevoflurane with total intravenous dexmedetomidine as the sole anesthetic maintenance agent in the respective arms. The primary outcome was Emergence Agitation measured with the Cravero scale from extubation at 15-minute intervals until complete awakening in the recovery room.

The registry reports mean scores of 3.9 (standard deviation 0.9) for sevoflurane and 2.5 (standard deviation 0.6) for dexmedetomidine. It separately reports an odds ratio of 40.955, a 95% confidence interval from 14.098 to 118.972, and p = 0.001 using a corrected chi-squared analysis. The record does not explain how that categorical analysis relates to the continuous means or identify the odds-ratio direction. It also reports zero serious adverse events, other adverse events, and deaths in both groups. Important details about analysis populations, missing data, and the statistical plan are not reported in the registry record.