This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care (NCT00355368), a randomized phase 4 study. The primary outcome is Number of Participants Exhibiting Desaturation >5%.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00355368 |
| Phase | Phase 4 |
| Condition | Intubation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 420 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University Hospital, Basel, Switzerland |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing emergency intubation in intensive care. The primary outcome is described for the intention-to-treat population; further eligibility details are not reported in the registry record.
Intervention
Succinylcholine, a neuromuscular blocking agent used in the study for emergency intubation.
Comparator
Rocuronium, compared with succinylcholine as the alternative neuromuscular blocking agent.
Primary question
How did the number of participants with a decrease in oxygen saturation greater than 5% compare between the two groups, from the start of the intubation sequence through 2min after intubation was completed?
The registry describes emergency intubation in intensive care as a high-risk procedure. Its stated rationale is that succinylcholine had long been a commonly used agent, but could have serious side effects and be contraindicated in conditions relevant to intensive care. Rocuronium was proposed as an alternative. The record notes that prior evidence in elective cases did not resolve whether the agents differed in emergency intensive-care cases.
The study therefore considered more than oxygen desaturation. Its aims also included intubating conditions, the length of the intubating sequence, failed attempts, and hemodynamic consequences. These outcomes address different aspects of the procedure, so a comparison on one outcome does not automatically answer the others. The posted primary result concerns desaturation; it should not be treated as a complete assessment of every procedural outcome or of overall safety.
3. Trial Design
The registry identifies this as a phase 4, randomized, single-masked, parallel-group study comparing succinylcholine with rocuronium. The listed enrollment is 420. The posted primary outcome summaries use 200 participants in each treatment group, while the adverse-event summaries list 210 at risk in each group. These are the denominators attached to the respective registry results; the record does not explain the difference between them.
The sponsor was University Hospital, Basel, Switzerland. The recorded start and primary completion are both 2006-08, and the study status is completed. Those registry dates do not provide a more detailed account of recruitment or follow-up. The record does not say who was masked, describe how the random sequence was generated or concealed, or give further detail about allocation procedures. Such details are not reported in the registry record.
The primary endpoint is the number of participants with a decrease in oxygen saturation greater than 5%, measured continuously by pulse oximetry during the specified interval around intubation. The primary population is identified as ITT. Secondary outcomes include hemodynamic sequelae, time to completion of intubation, a validated intubation-condition score, and failed first intubation attempts. Numerical results are posted for time, score, and failed attempts; numerical results for hemodynamic sequelae are not reported in the registry record.
The record identifies the study as randomized, but the detailed protocol, the original sample-size justification, and the prespecified statistical analysis plan are not reported in the registry record. The planning illustrations associated with the posted results are based on the observed effects and stated assumptions; they should not be mistaken for the original design rationale.
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
| Stage | Succinylcholine | Rocuronium |
|---|---|---|
| STARTED | 210 | 210 |
| COMPLETED | 200 | 201 |
| NOT COMPLETED | 10 | 9 |
Reasons for not completing this period:
| Reason | Succinylcholine | Rocuronium |
|---|---|---|
| Protocol Violation | 8 | 7 |
| cardiac arrest prior to intubation | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: ITT
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.
| Characteristic | Unit | Succinylcholine | Rocuronium | Total |
|---|---|---|---|---|
| Participants analysed | 210 | 210 | 420 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 123 | 108 | 231 |
| Age, Categorical: >=65 years | Participants | 87 | 102 | 189 |
| Age Continuous | years | 60 (SD 16) | 63 (SD 14) | 61 (SD 15) |
| Sex: Female, Male: Female | Participants | 91 | 93 | 184 |
| Sex: Female, Male: Male | Participants | 119 | 117 | 236 |
| Region of Enrollment: Switzerland | participants | 210 | 210 | 420 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Exhibiting Desaturation >5%, measured over at any time between the start of the intubation sequence and 2min after the completion of intubation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants whose oxygen saturation decreased by more than 5% at any time from the start of the intubation sequence until 2min after completion of intubation. Oxygen saturation was measured continuously using pulse oximetry. The reported measure is a count of participants meeting this threshold, rather than the size or duration of each participant’s decrease.
A threshold-based endpoint gives a defined way to compare the frequency of a specified event between groups. In this trial, desaturation is relevant to the immediate period surrounding emergency intubation, and the endpoint’s time window is explicitly linked to the procedure. The measure does not, by itself, describe other aspects of oxygenation, the severity of events beyond the threshold, or consequences after the stated window. Those matters are not established by this endpoint.
The registry labels the primary population ITT. The posted counts are 73 of 200 for succinylcholine and 66 of 200 for rocuronium. The unadjusted risk difference, comparing rocuronium with succinylcholine, is -0.035. Its confidence interval includes zero, and the unadjusted p-value is 0.462. These summaries describe the observed data and their uncertainty; they do not establish that the treatments are equivalent or that a difference is absent.
7. Results Posted in the Registry
- Rocuronium: 33.0% (66/200) versus 36.5% (73/200) on control; risk difference -3.5 percentage points (95% CI -12.8 to 5.8), risk ratio 0.90 (0.69–1.18); unadjusted two-proportion z-test p = 0.462.
Risk difference: Rocuronium
95% CI: -12.8 to 5.8 percentage points
Recalculated from the posted summary statistics
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.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Time to Completion of Intubation | Continuous Endpoint | Mean difference | 14.00 (5.52 to 22.48) | 151 per arm |
| Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74. | Continuous Endpoint | Mean difference | -0.10 (-0.27 to 0.07) | 1,139 per arm |
| Number of Participants With an Failed First Intubation Attempts | Binary Endpoint | Risk difference | +2.0 pts (-5.4 to 9.4) | 5,537 per arm |
Time to Completion of Intubation
- 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:
- Rocuronium: mean 95.00 versus 81.00 on control; difference 14.00 (95% CI 5.52 to 22.48), standardized effect d = 0.32; z-test p = 0.001.
- Interpretation:
- The 95% confidence interval excludes no difference, so the mean is statistically higher for Rocuronium than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.
- 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:
- Rocuronium: mean 8.20 versus 8.30 on control; difference -0.10 (95% CI -0.27 to 0.07), standardized effect d = -0.12; z-test p = 0.240.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Rocuronium and the control. The interval gives the range of effects that remain compatible with the data.
Number of Participants With an Failed First Intubation Attempts
- Endpoint type: Binary: the number of participants with the event, compared as proportions.
- Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
- Result:
- Rocuronium: 18.0% (36/200) versus 16.0% (32/200) on control; risk difference 2.0 percentage points (95% CI -5.4 to 9.4), risk ratio 1.12 (0.73–1.74); unadjusted two-proportion z-test p = 0.594.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Rocuronium and the control. The interval gives the range of effects that remain compatible with the data.
The secondary endpoints examine different parts of emergency intubation: elapsed time, the quality score, failed first attempts, and hemodynamic sequelae. The posted numeric summaries suggest a longer average time in the rocuronium group, while the score and failed-attempt comparisons do not show a clear separation. Hemodynamic sequelae are named among the outcomes, but numerical results are not reported in the registry record.
This pattern complements rather than overturns the primary result. Desaturation measures a threshold event during a defined period around intubation; time and intubation conditions capture other procedural features. A result on one endpoint cannot be used as a proxy for another, and the secondary summaries do not establish a unified overall advantage for either group. The secondary outcome results also do not resolve uncertainty in the primary estimate.
The posted secondary p-values are unadjusted. When multiple outcomes are examined, the chance of at least one apparently notable result can increase, depending on the analyses and their relationships. No multiplicity strategy is reported, so the secondary findings carry less confirmatory weight than a prespecified result interpreted under a documented analysis plan. This is especially relevant when there are several distinct outcomes and the registry record does not explain which comparisons were designated as confirmatory or how their interpretation was prioritized.
These are registry summaries, not a complete account of the underlying outcome distributions or adjusted analyses. The record does not provide numerical hemodynamic results, and it does not report additional analyses that could address differences in baseline characteristics or missing observations. The appropriate reading is therefore outcome-specific and cautious: note the overall directions, retain the uncertainty around estimates, and avoid treating a single secondary result as a definitive account of the comparison.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Haemodynamic Sequelae of Intubation
- Time to Completion of Intubation
- Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.
- Number of Participants With an Failed First Intubation Attempts
9. Statistical Interpretation
For the primary endpoint, the registry reports 73 participants with desaturation in the succinylcholine group and 66 in the rocuronium group, with 200 participants in each group. The posted risk difference, defined as rocuronium minus succinylcholine, is -0.035. Thus the point estimate is in the direction of fewer threshold-defined desaturation events with rocuronium. The confidence interval includes zero, and the unadjusted p-value is 0.462. The result is compatible with a range of effects, including no difference and effects in either direction; it does not provide strong evidence of a between-group difference on this endpoint.
This should not be translated into proof that the agents have the same effect. A non-significant p-value does not show equivalence, and the registry does not report an equivalence or non-inferiority framework. Nor does the point estimate alone establish a clinically important difference. Clinical importance requires context and criteria not reported in the registry record.
The secondary findings address distinct questions. The posted mean time to completion was 81.0 seconds with succinylcholine and 95.0 seconds with rocuronium; the mean difference was 14.0 seconds, with p = 0.001. The average intubation-condition scores were 8.3 and 8.2, with a small posted difference and p = 0.24. Failed first attempts were reported for 32 participants in the succinylcholine group and 36 in the rocuronium group, with p = 0.594. Hemodynamic sequelae are listed as an outcome, but their numerical results are not reported in the registry record.
The secondary outcomes do not all point to the same kind of comparison: time is longer on average in the rocuronium group, while the score and failed-attempt summaries do not give clear evidence of group differences. The results are unadjusted, and the record does not describe how multiplicity was handled. They are therefore best read as separate, exploratory summaries rather than as a single confirmatory verdict. The primary result remains specific to desaturation, and none of these outcomes alone represents the full balance of procedural benefits and harms.
10. Statistical Methods Explained
The registry posts group-level counts for binary outcomes and group means with standard deviations for continuous outcomes. The comparisons are unadjusted summaries. The registry record does not report the full statistical analysis plan, the methods used to generate the posted p-values, or any adjusted estimates. Consequently, interpretation should focus on the reported estimates and uncertainty rather than assume details of an analysis that are not documented.
What does a risk difference express?
For a binary endpoint, a risk difference compares the proportion meeting the endpoint in one group with the proportion in the other. The comparison is oriented as rocuronium minus succinylcholine. A negative value therefore means the observed proportion was lower in the rocuronium group; a positive value means it was higher. The primary risk difference is -0.035. This is an absolute comparison, not a relative risk or odds ratio. The registry also posts relative measures, but the risk difference makes the direction and absolute scale of the comparison explicit.
The count-based endpoint is not a count of repeated events. It is the number of participants who met the defined event criterion. More generally, for count data that can include multiple events per participant, variation may exceed what a simple Poisson model assumes; that is called over-dispersion and can affect uncertainty estimates. That general issue should not be read as a description of the model used: the registry does not report a count-model analysis, and the primary outcome is posted as participants with an event.
How should a mean difference be read?
For a continuous endpoint, the mean difference compares the reported group averages, with rocuronium minus succinylcholine. A positive difference for time means the reported average time was longer in the rocuronium group. Standard deviations describe variation among observations within a group; they are not confidence intervals for the group means. The mean time and standard deviation are 81.0 and 38.0 seconds for succinylcholine, and 95.0 and 48.0 seconds for rocuronium. The posted mean difference is 14.0 seconds.
The quality score is also summarized as a mean and standard deviation. Its unit is score points, and the stated measurement period is during laryngoscopy and the first minute after completion of intubation. A group mean describes the average score, not the distribution of individual scores or the proportion of participants with any particular score. The record refers to a validated score but does not provide further details about its interpretation or a threshold for a clinically important difference.
What do p-values contribute?
A p-value describes how incompatible the observed result is with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The registry reports unadjusted p-values. Because the analysis method and any adjustment plan are not reported in the registry record, these values should be read as posted rather than attributed to a more detailed procedure.
The primary p-value is 0.462. For time, it is 0.001; for the quality score, 0.24; and for failed first attempts, 0.594. These values should be interpreted alongside estimates and confidence intervals, not as stand-alone labels. In particular, a p-value above a conventional threshold does not establish equivalence, while a small p-value does not by itself establish practical importance.
What are the planning illustrations?
The sample-size illustrations use the observed effect as a starting point, consider the stated fractions of that effect, and apply a two-sided significance level of 0.05, equal allocation, and a normal approximation. For the posted binary and continuous outcomes, the figures are participants per arm. They are planning calculations, not the original trial design assumptions. The trial’s own sample-size justification and the assumptions behind its original design are not reported in the registry record.
In general, a confidence interval describes a range of effect estimates compatible with the data under the interval method and its assumptions. A narrower interval indicates greater precision; a wider interval indicates greater uncertainty. The intervals in this trial should be considered with the group summaries and the limitations of registry reporting. The record does not state whether there were interim analyses, missing-data procedures, or sensitivity analyses.
11. Confidence Intervals and Precision
The primary risk difference is -0.035, with a confidence interval that includes zero. The estimate favors a lower observed event proportion in the rocuronium group, but the interval also allows for no difference and for effects in the opposite direction. Its breadth means the result is not precise enough to distinguish among all of those possibilities. The unadjusted p-value of 0.462 is consistent with the interval’s lack of clear separation from zero; neither statistic proves that there is no effect.
For time to completion, the posted mean difference is 14.0 seconds, and its confidence interval lies above zero; the unadjusted p-value is 0.001. This gives more evidence of a difference in average time than the primary endpoint gives for a difference in desaturation. The interval still expresses uncertainty about the size of the mean difference, and the registry record does not define what time difference would be clinically important.
The confidence intervals for the quality score and failed first attempts include zero. Their estimates therefore do not rule out no difference, while also allowing effects in either direction. Across endpoints, precision depends on the outcome, the observed variability or event frequency, and the amount of information in the analysis. A confidence interval is not a guarantee that the true effect lies within its limits; it is an uncertainty summary interpreted under the method’s assumptions.
The posted denominators are outcome-specific summaries, and the record does not explain why the adverse-event risk sets differ from the outcome denominators. This limits what can be inferred about how participants were included in each analysis. The registry also does not report missing-data details or adjusted estimates. Those omissions matter when judging how fully the posted intervals represent uncertainty in the underlying comparison.
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.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 2,905 | 3,888 |
| 75% of the observed effect | 5,195 | 6,954 |
| 50% of the observed effect | 11,755 | 15,735 |
The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes or total event counts: the listed outcomes are binary or continuous, and the planning assumption states that all outcomes other than time-to-event tables are expressed as participants per arm. There is no time-to-event endpoint among the posted results.
Power is the probability that a study design will identify an effect of a specified size as statistically significant under the assumptions used in the calculation. The 80% and 90% columns represent different target probabilities: the 90% target requires more participants per arm than the 80% target for a given assumed effect. The illustrations apply a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They consider effects set at 100%, 75%, and 50% of the observed effect.
As the effect to be detected becomes smaller, the planning figures increase. This reflects the general requirement for more information to distinguish a smaller effect from random variation. The calculations begin with effects observed in this trial, so they are not a substitute for a prospective design based on a clinically important target and prespecified assumptions. They are not observed power. The original trial’s sample-size rationale and design assumptions are not reported in the registry record.
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 z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, p0 and p1 are the control and treatment proportions, and p̄ is their average.
Worked calculation for this trial
- Control proportion p0 = 0.365; treatment proportion p1 = 0.330; average p̄ = 0.348.
- First term: z1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6734 = 1.3199.
- Second term: z1−β × √[p0(1−p0) + p1(1−p1)] = 0.842 × 0.6730 = 0.5664.
- n = (1.3199 + 0.5664)2 / (-0.0350)2 = 2,904.4, rounded up to 2,905 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
p0 <- 0.365 # control proportion
p1 <- 0.33 # treatment proportion
n_per_arm <- function(power, frac = 1) {
q1 <- p0 + (p1 - p0) * frac # smaller effect = fraction of the observed difference
pbar <- (p0 + q1) / 2
z_b <- qnorm(power)
ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")
# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(355368)
n <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))
Output from running the code
100% of observed effect: n per arm = 2,905 (80% power), 3,888 (90% power)
75% of observed effect: n per arm = 5,195 (80% power), 6,954 (90% power)
50% of observed effect: n per arm = 11,755 (80% power), 15,735 (90% power)
power.prop.test: 2904.4
Simulated power at n = 2,905 per arm: 0.797 (20000 replicates)
The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 lists multiple outcomes, including one primary endpoint and several secondary measures. It reports unadjusted comparisons for the posted numeric results, but does not report a plan for controlling multiplicity or explain how the outcomes were prioritized in the statistical analysis. When several outcomes are tested, chance findings become more likely if each is interpreted as an independent confirmatory test. Without a stated strategy, the secondary p-values should be viewed as exploratory signals rather than a family of results with a documented error-rate guarantee.
The primary population is labeled ITT, but the registry record does not describe the operational rules used to define that population, how participants were handled if an outcome was unavailable, or whether all randomized participants contributed to each analysis. It does not report missing-data counts, reasons for missingness, imputation procedures, or sensitivity analyses. The posted primary outcome denominators are 200 in each group, whereas adverse-event summaries list 210 at risk in each group; the record does not explain this difference. These figures should be kept tied to their respective outcomes rather than combined or reconciled by assumption.
The record identifies randomization and single masking, but does not provide further detail about the sequence generation, allocation concealment, identity of the masked parties, or whether masking was maintained. It also does not report an interim-analysis plan, stopping rules, or the original sample-size justification. These are not grounds to infer that a particular procedure was or was not used; they are details not reported in the registry record.
As a result, the posted estimates can be described, but a full assessment of analytic robustness is not possible from the registry information alone. The absence of documentation does not demonstrate a flaw; it limits what readers can verify about analysis choices, missing outcomes, and the interpretation of multiple comparisons.
15. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Succinylcholine | 0 | 210 | 0.0% |
| Rocuronium | 0 | 210 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Succinylcholine | 0 of 210 |
| Rocuronium | 0 of 210 |
The adverse-event summaries list 210 participants at risk in each group. For both succinylcholine and rocuronium, the registry reports zero participants affected by serious adverse events and zero affected by other adverse events in those summaries. The death fields are null, so deaths are not reported in the registry record; a null field should not be read as a reported zero.
These figures are limited to the registry’s posted adverse-event summaries. The record does not provide event descriptions, severity categories beyond the serious and other groupings, timing, follow-up details, or an explanation of the risk-set denominators. Zero reported affected participants in these fields does not establish that no adverse events occurred outside the registry’s reporting scope, nor does it establish comparable safety. The figures should be interpreted as what the record reports, not as a comprehensive safety assessment.
16. What the Result Does, and Does Not, Mean
The primary comparison is about a defined desaturation threshold during a defined period around emergency intubation. The observed counts were 73 of 200 with succinylcholine and 66 of 200 with rocuronium. The risk difference estimate favors fewer such events with rocuronium, but its confidence interval includes zero and the unadjusted p-value is 0.462. The data do not provide clear evidence of a difference on this endpoint, and they do not establish that the treatments are equivalent.
The posted secondary results provide additional, outcome-specific information. Average time to completion was longer in the rocuronium group, whereas the quality-score and failed-first-attempt comparisons did not show clear differences. Hemodynamic results are not reported numerically. Because these outcomes measure different aspects of intubation, they should not be compressed into a single claim about the overall performance of either agent.
Statistical uncertainty and clinical importance are related but distinct. The estimates describe the observed comparisons; confidence intervals describe uncertainty under the analysis method. The registry does not specify a threshold for a clinically important difference in desaturation, time, or score, or an equivalence margin. It therefore does not support a conclusion about whether any possible difference would matter clinically.
Interpretation is also bounded by the information available in the registry. Detailed eligibility criteria, masking details, missing-data handling, multiplicity procedures, and the original sample-size rationale are not reported. The adverse-event fields are limited summaries, and the death fields are not populated. These results should be read as posted statistical evidence about selected outcomes, not as medical advice or a comprehensive assessment of benefits and harms.
17. Why This Trial Matters Statistically
This trial addresses a comparison in a setting that the registry distinguishes from elective intubation: emergency intubation in intensive care. The record’s rationale is that evidence in elective cases did not answer whether the agents differed in emergency cases. The study therefore illustrates why the clinical context and the outcome definition matter when interpreting a treatment comparison.
Statistically, the record offers a useful example of separating an estimate from its uncertainty. The primary risk difference points toward fewer threshold-defined desaturation events in the rocuronium group, but its confidence interval includes zero. That distinction prevents the point estimate from being overstated as decisive evidence. The secondary time result also shows why outcomes should be interpreted individually: evidence of a difference in one measure does not settle the primary endpoint or other aspects of the procedure.
The record also demonstrates the limits of posted summaries. Group counts and means can support clear descriptions, but unreported analysis plans, missing-data procedures, multiplicity handling, and event details constrain deeper evaluation. Planning illustrations based on observed effects can help explain how effect size relates to information needs, but they are not a record of the original design decision and do not establish the adequacy of the trial for a particular clinical question.
For biostatisticians and clinical researchers, the central lesson is to align claims with the endpoint, analysis population, uncertainty, and documentation actually available. Distinguishing absence of clear evidence from evidence of equivalence is particularly important when a confidence interval remains compatible with effects in either direction.
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 registry provides limited detail on eligibility, participant characteristics, procedural context, and the conduct of masking. Although the study is identified as randomized and single-masked, the record does not state who was masked or describe sequence generation and concealment. These omissions limit assessment of the trial’s conduct and of how broadly its results apply.
The outcome reporting is also incomplete for some questions. Hemodynamic sequelae are listed but have no numerical result in the registry record. The adverse-event summaries report zero affected participants in the listed categories, but do not provide event-level detail or explain their risk-set denominators; the death fields are null. Numerical outcome denominators and adverse-event denominators differ, and the record does not explain why. Missing-data counts and handling are not reported.
The registry does not report the original sample-size justification, a prespecified statistical analysis plan, multiplicity handling, or interim-analysis procedures. The posted comparisons are unadjusted, and no adjusted results are listed. Consequently, it is not possible to determine from the record how analyses were prespecified, how multiple outcomes were intended to be interpreted, or whether the posted results reflect all planned analyses.
Finally, the posted outcomes capture selected procedural measures and do not, by themselves, describe every clinically relevant consequence of intubation. The record supplies no clinically important thresholds for the continuous outcomes and no equivalence margin for the primary comparison. These limitations call for a bounded interpretation of the posted findings, rather than an assumption that unreported details favor or undermine either group.
19. Related Tutorials
20. Related Statistical Calculators
21. Sources
- ClinicalTrials.gov: Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care — NCT00355368.
- Registry record last updated 2011-12-15; status last verified 2011-11.
- Results first posted 2011-12-15.
- 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.
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22. Record Summary
NCT00355368 is a completed phase 4 randomized, single-masked, parallel-group study comparing succinylcholine with rocuronium for emergency intubation in intensive care. The listed enrollment is 420, and the recorded start and primary completion are both 2006-08.
The primary endpoint is the number of participants with a decrease in oxygen saturation greater than 5% during the specified interval around intubation. The posted counts are 73 of 200 for succinylcholine and 66 of 200 for rocuronium; the risk difference is -0.035, with an unadjusted p-value of 0.462 and a confidence interval that includes zero. Secondary summaries address time, a quality score, and failed first attempts; numerical hemodynamic results are not reported in the registry record.
The results describe observed comparisons, not proof of equivalence or a comprehensive safety assessment. Analysis details, missing-data handling, multiplicity procedures, and the original sample-size rationale are not reported in the registry record.