Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction (NCT05509192), a randomized phase 4 study. The primary outcome is The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation.

2. Clinical Question

3. Trial Design

The registry identifies this as a prospective, randomized, triple-masked, parallel-group phase 4 trial. It is registered as completed, with enrollment of 154. The listed sponsor is The University of Texas Health Science Center, Houston. The study start date is 2022-08-17, and the primary completion date is 2025-01-24. These administrative details describe the registered trial; they do not establish the timing or completeness of every outcome assessment.

Participants were assigned to MTPI or classic induction. The posted primary outcome summaries include 64.0 participants in the MTPI group and 68.0 in the classic induction group. The registry does not explain the difference between the overall enrollment figure and the group counts contributing to these summaries. Reasons for any difference, such as missing outcome observations or analysis-population rules, are not reported in the registry record.

Triple masking indicates that masking was part of the registered design, but the identities of the masked parties and the procedures used to preserve masking are not reported in the registry record. Details of the randomization sequence, allocation concealment, site structure, eligibility criteria, participant characteristics, and protocol deviations are also not reported. The arm descriptions in the record do not provide further procedural detail.

The registry lists 25 outcome measures and posts 24 secondary outcomes. It identifies the primary endpoint as the total time from laryngoscope insertion to the onset of ventilation, with a timeframe of less than 7 minutes. The trial has no posted analyses in the registry record. Consequently, the randomized design is clear, but the record does not provide the analysis procedures needed to determine how the registered design was carried through in the reported results.

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 The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation, measured over Between laryngoscope insertion to onset of ventilation (less than 7 minutes).

The primary endpoint measures elapsed time from insertion of the laryngoscope into the mouth to the onset of ventilation after tracheal intubation. The unit is seconds, and the registered timeframe is from laryngoscope insertion to the onset of ventilation within less than 7 minutes. This endpoint captures the duration of the intubation sequence as defined by the registry. It is not a measure of the time needed for induction as a whole, nor does it by itself describe whether an attempt was successful or whether complications occurred.

The record summarizes the endpoint using the median and inter-quartile range. The median represents the central observation after ordering times, while the inter-quartile range describes the span covering the middle half of observed times. These summaries are useful when a distribution may be skewed or contain unusually long times, because a median is less influenced by extreme observations than a mean. That is a general statistical reason to use these summaries; the registry does not report why this particular summary was selected.

The reported median was 30.0 seconds in the MTPI group, with an inter-quartile range of 22.0 to 41.5 seconds. In the classic induction group, the median was 33.0 seconds, with an inter-quartile range of 28.0 to 50.0 seconds. These are descriptive group summaries. A confidence interval, hypothesis test, or other inferential comparison for the primary endpoint is not reported in the registry record, so the summaries alone do not establish the precision of a between-group difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is summarized with medians and inter-quartile ranges rather than means and standard deviations. In general, the median identifies the middle of an ordered distribution, while the inter-quartile range describes the central spread. This approach can be informative when elapsed times are asymmetric or have a long tail. The registry gives no reason for its choice of summary and does not provide the individual observations or a distributional plot from which the shape of the timing data could be assessed.

A descriptive comparison of medians is not the same as a formal comparison between groups. An inferential analysis would normally specify an effect measure and quantify its uncertainty, for example with a confidence interval, and might report a test result. No such primary comparison is reported in the registry record. Because the outcome is summarized by median and inter-quartile range, the posted values cannot be used to reconstruct an exact primary confidence interval or a valid test without further assumptions and data. Any such reconstruction would go beyond the registry summaries.

A confidence interval, in general, expresses the uncertainty associated with an estimated effect under the assumptions of the analysis used. Its width depends on the amount and variability of information available, as well as on the method. A confidence interval for a group contrast would be more informative about the primary question than separate ranges describing the within-group distributions. The posted inter-quartile ranges are not confidence intervals: they describe the spread of observed times, not uncertainty in the estimated difference.

Some secondary comparisons use means and standard deviations. For these outcomes, the posted unadjusted calculations compare the classic induction group with the MTPI group using a mean difference and a confidence interval. A mean difference describes the contrast between group means in the original measurement units. The confidence interval gives a range of values compatible with the estimate under the assumptions of the calculation. These are recalculated comparisons from the posted summaries, not sponsor-reported analyses; the registry lists no reported analyses. Because they are unadjusted, they do not account for multiple secondary comparisons or any covariates.

For the first-attempt outcome, the registry gives participant counts in each group. A risk difference is a difference between group proportions, while a risk ratio compares those proportions as a ratio. In general, such effect measures answer different questions, and their confidence intervals can be wide when event counts are sparse or group sizes are limited. The unadjusted p-value for this outcome is 0.951. A p-value describes how unusual data at least as incompatible with a null hypothesis would be under the test assumptions; it does not measure the probability that the null hypothesis is true, nor does it show that the groups are equivalent.

The minimum systolic blood pressure comparison has an unadjusted mean difference of -13.2 mmHg, a confidence interval from -21.83 to -4.57, and p = 0.003. For maximum systolic blood pressure, the unadjusted mean difference is -5.4 mmHg, the confidence interval runs from -13.34 to 2.539, and p = 0.182. These should be read as secondary calculations. The registry does not report a prespecified hierarchy among secondary outcomes or a correction for multiplicity, so the p-values should not be treated as confirmatory evidence on their own.

Planning calculations associated with the posted secondary contrasts are illustrations rather than observed trial properties. They use the observed effect as a starting point and consider smaller fractions of that effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. Their purpose is to illustrate how assumed effect size relates to a prospective sample-size target under those assumptions. They are not evidence that the trial had a particular power, are not the trial's original sample-size justification, and should not be mistaken for the number enrolled or analyzed. The trial's own sample-size justification is not reported in the registry record.

General statistical considerations also matter for duration and blood pressure outcomes. If observations are highly skewed, a mean-based method may be sensitive to extreme values; if variances differ, methods that assume similar variances may give misleading uncertainty. Over-dispersion, in general, means that observed variability exceeds what a chosen model expects and can make standard errors too small if ignored. The registry does not report diagnostic checks, model specifications, transformations, robust methods, or sensitivity analyses. It is therefore not possible to assess how these issues were handled.

Finally, an analysis should define which randomized participants contribute to each outcome, how missing measurements are addressed, and whether the analysis follows the randomized allocation. Such choices can affect both estimates and uncertainty. The registry record does not report the analysis population or missing-data procedures. The posted group counts should therefore be interpreted as the counts accompanying the reported summaries, not as a complete description of the analysis strategy.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 25 outcome measures and posts 24 secondary outcomes. It reports no analyses. A formal multiplicity strategy, such as a testing hierarchy or adjustment across outcomes, is not reported in the registry record. This matters because interpreting a collection of unadjusted tests as if each were the only test can overstate the strength of evidence. The secondary p-values should therefore be treated cautiously and should not be read as confirmatory without a documented plan.

The primary endpoint has descriptive summaries by group, but the record does not report an inferential comparison. The absence of a primary test or confidence interval also makes it difficult to understand whether the primary analysis was prespecified and how its result was interpreted relative to the secondary outcomes. The registry does not report an analysis plan, interim analyses, or a sample-size justification. It would be inappropriate to infer any of these procedures from the posted summaries.

Missing-data handling and analysis populations are not reported in the registry record. The primary summaries list 64.0 participants for MTPI and 68.0 for classic induction, while overall enrollment is 154. The record does not explain the difference between those figures, identify how many randomized participants lacked the endpoint, or give reasons for any exclusions. It also does not state whether analyses followed randomized allocation, whether participants were included according to treatment received, or whether any other analysis population was used.

The registry does not describe imputation, complete-case analysis, sensitivity analyses, or handling of protocol deviations. These omissions limit assessment of whether missing outcomes could have influenced the reported summaries. They also prevent evaluation of how well the reported analyses preserve the protections intended by randomization. This is a limitation of what can be learned from the registry record, not evidence that a particular procedure was or was not used outside the record.

11. 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 77 participants at risk in the MTPI group and zero among 77 participants at risk in the classic induction group. It also reports zero other adverse events in each group and zero deaths in each group. These are the event counts recorded in the registry, not a guarantee that no adverse event can occur.

Zero observed events do not establish that the underlying risk is zero. With no events recorded, the registry figures cannot define the range of event rates that would remain compatible with the data. The at-risk counts accompanying the safety figures also differ from the group counts accompanying the primary outcome summaries. The registry does not explain the relationship between these counts, the safety observation period, or how adverse events were collected and classified.

The serious adverse event figures should therefore be read narrowly: no serious events were recorded in the listed at-risk groups during the registry's safety reporting. The record does not provide additional details about event ascertainment, severity definitions, follow-up completeness, or individual event narratives. These figures describe what was posted and do not establish comparative safety beyond the limits of the registry data.

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

The posted results describe intubation times in the MTPI and classic induction groups and provide selected secondary summaries. The primary medians and inter-quartile ranges show where observed times were centered and how the middle portions of the distributions varied. The registry does not report a primary between-group effect estimate, confidence interval, or test. As a result, the primary summaries do not establish the size or precision of a difference between induction approaches.

The secondary calculations provide additional, unadjusted information about first-attempt success and systolic blood pressure. They address separate outcomes, and their interpretation is weakened by the absence of a reported analysis plan and multiplicity procedure. Their p-values do not answer the primary timing question. Nor do they show that all registered secondary outcomes were assessed or reported.

The randomized, triple-masked, parallel design is an important feature of the registered study. However, the registry does not describe the masking procedures, randomization implementation, analysis populations, missing-data methods, or the statistical plan. These omissions limit assessment of how the trial was conducted and analyzed. The posted safety figures likewise report zero events but cannot rule out risks or fully characterize event ascertainment.

These registry results should not be turned into medical advice or a conclusion that either induction approach is effective or ineffective. They are a record of descriptive outcomes and selected unadjusted calculations, with important gaps in inferential reporting. A stronger statistical interpretation of the primary question would require a reported primary comparison with uncertainty, along with sufficient detail about the population analyzed, missing observations, and analysis methods.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its primary endpoint is a time measure summarized by medians and inter-quartile ranges, while the registry does not report a formal primary comparison. That distinction illustrates why group summaries and an estimate of a group contrast serve different purposes. Descriptive summaries show the observed data within each group; an inferential comparison is needed to quantify the uncertainty around the contrast relevant to the randomized question.

The registry also illustrates how a trial can have a randomized and masked design yet still leave important questions unanswered in its posted statistical record. The allocation and masking labels describe design features, but they do not reveal how randomization was implemented, which parties were masked, or how the primary analysis was performed. A clear account of the analysis population and missing data is needed to interpret the link between enrollment and reported group summaries.

The secondary outcomes offer a further statistical lesson. Multiple measures may describe different facets of a procedure, but unadjusted comparisons across outcomes do not carry the same weight as a prespecified primary analysis. Without a reported multiplicity strategy, isolated p-values can be over-interpreted. Planning illustrations based on observed effects also need careful distinction from prospective design justification or observed power; they cannot establish that the original trial was adequately powered.

For clinical researchers, the record emphasizes the value of reporting an effect estimate with its uncertainty, a transparent analysis plan, and clear accounting of outcome availability. For biostatisticians, it underscores the limits of reconstructing results from summaries alone. The calculations that can be made from posted summaries remain unadjusted and cannot replace a prespecified, fully reported analysis of the primary endpoint.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation specific to this trial record is that the primary endpoint is reported descriptively, without a between-group inferential analysis. The median and inter-quartile range in each group do not quantify the uncertainty of the contrast. The registry lists zero analyses, and the sponsor's primary analysis is not reported in the registry record. Consequently, the primary comparison cannot be evaluated with a registry-reported confidence interval or test.

There is also limited detail about the study population and conduct. Eligibility criteria, participant characteristics, regimen specifics, randomization procedures, allocation concealment, and the identities of masked parties are not reported. The arm descriptions add no detail about the interventions. These gaps make it difficult to assess generalizability, procedural consistency, and the potential for deviations from the intended design.

The primary summaries include 64.0 and 68.0 participants in the two groups, while enrollment is recorded as 154. The registry does not explain the relationship between enrollment and the group counts contributing to the primary summaries. It does not report missing-data procedures, reasons for unavailable outcomes, or the analysis population. The safety figures use at-risk counts of 77 in each group, and the relationship of those counts to the primary outcome populations is not explained.

Several secondary outcomes are registered, but only selected numerical secondary results are available in the record. A multiplicity procedure and prespecified hierarchy are not reported, so the unadjusted secondary comparisons are difficult to interpret as confirmatory. The registry also provides no primary sensitivity analysis, diagnostic checks, model details, or reported analyses from the sponsor. These limitations concern the evidence available in the registry record and do not establish what analyses may have been conducted elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction — NCT05509192.
• Registry record last updated 2026-02-11; status last verified 2026-01.
• Results first posted 2026-02-11.
• 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.

18. Record Summary

NCT05509192 is a completed, randomized, triple-masked, parallel-group phase 4 trial sponsored by The University of Texas Health Science Center, Houston. It compared Modified Time Principle Induction with classic induction for tracheal intubation, with enrollment recorded as 154. The study start date is 2022-08-17, and the primary completion date is 2025-01-24.

The primary outcome was time from laryngoscope insertion to onset of ventilation, summarized by median and inter-quartile range. The registry posts group summaries but no primary inferential comparison. Selected secondary outcomes have posted counts and unadjusted calculations, while results for other registered measures and details of multiplicity, missing-data handling, and analysis populations are not reported in the registry record. The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in each group.