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 Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery. (NCT02330172), a randomized na study. The primary outcome is Laryngoscopic Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02330172 |
| Phase | NA |
| Condition | Neuromuscular Blockade |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 44 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Seoul National University Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants undergoing laryngeal microsurgery in the setting of neuromuscular blockade. The registry record lists neuromuscular blockade as the condition and records enrollment of 44. Further eligibility details, participant characteristics, and the analysis population are not reported in the registry record. This means the clinical question can be described only for the broad surgical context named in the record, not for a more narrowly defined patient group.
Intervention
One arm is described as receiving rocuronium 0.9 mg/kg at anesthetic induction, with sugammadex identified in the arm name. The study summary frames this as a comparison of rocuronium 0.9 mg/kg and sugammadex with the other regimen. The arm description also contains an unclear statement about which reversal agent is given at the end of the operation, so the details of administration are not fully consistent in the registry record.
Comparator
The comparator arm is identified as rocuronium 0.45 - neostigmine. Its description says rocuronium 0.45 mg/kg is given for muscle relaxation at anesthetic induction, followed by an injection of neostigmine or sugammadex at the end of the operation. The record therefore identifies the intended regimen in the arm name and summary, while leaving ambiguity in the detailed wording about the reversal injection.
Primary question
The primary outcome is laryngoscopic score, rated by the surgeon at the beginning of surgery. The registry describes categories labeled Excellent, Good, and Poor, and gives verbal definitions related to jaw relaxation and resistance to blade insertion or laryngoscopy. The central question is whether the recorded distribution of surgical-condition ratings differs between the two regimens. Category counts and a comparative result are not reported in the registry record, so the direction and precision of any observed difference cannot be assessed.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study. Its status is completed, and enrollment is recorded as 44. The sponsor is Seoul National University Hospital. The record gives a start date of 2014-05 and a primary completion date of 2015-08. The phase is listed as NA. These details describe the registered study structure; they do not establish how randomization or masking was implemented in practice.
The two named arms compare rocuronium 0.45 mg/kg with neostigmine against rocuronium 0.9 mg/kg with sugammadex. The summary says the study aims to compare surgical condition and recovery time. The arm descriptions place rocuronium at anesthetic induction and describe a reversal injection at the end of the operation. However, the detailed wording for both arms includes ambiguity about whether neostigmine or sugammadex is used at that point. The exact administration procedures are therefore not fully clear from the registry record.
The primary outcome is a surgeon-rated laryngoscopic score at the beginning of surgery. Recovery time from neuromuscular blockade is listed as a secondary outcome. Although the registry identifies two outcome measures and two analyses, it does not report the outcome values, analysis methods, or comparative estimates. It also does not report the masking target, sequence generation, allocation concealment, sample-size justification, or a detailed statistical analysis plan. Those omissions limit what can be concluded about how the study was conducted and how its results were evaluated.
For safety, the registry lists 22 participants at risk in each arm. It records zero serious adverse events, zero other adverse events, and zero deaths in each arm. These are recorded counts, not evidence that every possible harm was assessed or that no events occurred outside the registry’s reporting scope.
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 | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex |
|---|---|---|
| STARTED | 22 | 22 |
| COMPLETED | 19 | 21 |
| NOT COMPLETED | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor
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 | Rocuronium 0.45 - Neostigmine | Rocuronium 0.9 - Sugammadex | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 22 | 44 | |
| Age, Categorical: Population from 18 years to 65 years – <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Population from 18 years to 65 years – Between 18 and 65 years | Participants | 22 | 22 | 44 |
| Age, Categorical: Population from 18 years to 65 years – >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 6 | 10 | 16 |
| Sex: Female, Male: Male | Participants | 16 | 12 | 28 |
| Race/Ethnicity, Customized: Number of South Korean participants | Participants | 22 | 22 | 44 |
| Region of Enrollment: Korea, Republic of | participants | 22 | 22 | 44 |
6. Primary Endpoint
The registry lists the primary outcome as Laryngoscopic Score, measured over At the beginning of surgery, the surgeon rated the laryngoscopy condition.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is laryngoscopic score, a categorical assessment of the conditions encountered during laryngoscopy at the beginning of surgery. The surgeon’s rating is described using categories labeled Excellent, Good, and Poor. The accompanying definitions distinguish conditions by jaw relaxation and resistance during blade insertion or laryngoscopy: an easy condition involves a relaxed jaw and no resistance, a fair condition involves incomplete relaxation and slight resistance, and a difficult condition involves poor relaxation and active resistance.
This kind of endpoint is used to represent the immediate procedural conditions relevant to the operation. It converts a clinical judgment into ordered descriptive categories, allowing the study to compare the pattern of ratings between treatment groups. Because categories carry different meanings, interpretation depends on knowing how many participants were assigned to each category in each arm and how the categories were analyzed.
The registry record does not report category counts or a treatment comparison. It also does not explain how the labels Excellent, Good, and Poor map onto the separate definitions phrased as Easy, fair, and difficult. No scoring procedure, assessor training, or reliability information is reported. Without the recorded distributions and a clear mapping, the endpoint’s observed result and its precision cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the comparison and the outcomes of interest, but it does not report the primary outcome results. Laryngoscopic score is described as a categorical surgeon rating, with categories labeled Excellent, Good, and Poor. The record provides verbal definitions based on jaw relaxation and resistance, but it gives no category counts by arm, no effect estimate, and no uncertainty interval. Consequently, the posted record does not support a conclusion about whether surgical-condition ratings differed between the regimens, how large any difference might have been, or how precisely it was estimated.
The secondary outcome, recovery time from neuromuscular blockade, is named but its results are also not reported in the registry record. No recovery-time summaries, comparison, or measure of uncertainty are available in the record. The study summary states that surgical condition and recovery time were the intended subjects of comparison; an aim is not itself a result.
The safety figures report zero serious adverse events, zero other adverse events, and zero deaths in each arm, with 22 participants at risk per arm. These counts describe what the registry lists. They do not establish that there was no risk, because a count of zero in a study of this size and reporting scope cannot rule out events that are uncommon, unrecorded, or not captured by the definitions used. The registry does not provide further details on event definitions, observation duration, or the method used to collect adverse-event information.
Randomization is recorded, which identifies the intended allocation approach, but important implementation details are not reported in the registry record. Nor are the analysis population, handling of missing observations, or statistical model described. Without those details and without outcome values, readers cannot assess whether the analyzed groups remained comparable, how incomplete data might affect estimates, or whether the reported analysis followed a prespecified plan.
Accordingly, the defensible interpretation is limited to the study’s registered design, named outcomes, and listed safety counts. No treatment effect, uncertainty, or evidence of equivalence can be inferred from the absence of outcome results. A nonsignificant result, a similar result, or a favorable result for either regimen cannot be claimed because no such comparative finding is reported in the registry record.
9. Statistical Methods Explained
The registry identifies a randomized, single-masked, parallel-group design. In general, random allocation is intended to reduce systematic differences between treatment groups at the point of assignment. It does not guarantee that the groups will be identical, especially in a study with limited enrollment, and it does not remove the need to describe how the allocation sequence was generated and concealed. Those implementation details are not reported in the registry record, so the quality of the randomization process cannot be evaluated from the record alone.
What does single masking tell readers?
In general, masking means keeping information about assigned treatment from specified people involved in a study. This can reduce the influence of expectations on care, assessment, or reporting, depending on who is masked. The label single-masked does not identify which people were masked. The masked party and practical masking procedures are not reported in the registry record. That distinction matters for a surgeon-rated outcome, because an assessor’s knowledge could potentially influence a subjective rating. The record does not establish whether the surgeon who rated laryngoscopy was masked.
How should a categorical endpoint be analyzed?
In general, categorical outcomes are described by counts in each category and group. A comparison may use a method suited to the category structure and the study question. For an outcome with ordered categories, an analysis might preserve that ordering, while another approach might treat categories as separate groups. These approaches answer different questions and can yield different estimates. The registry gives category labels and verbal definitions, but does not report the category counts or the statistical method used. It is therefore not possible to determine what comparison was performed or whether it respected the ordering of the ratings.
Clear outcome definitions are also important. The record labels the categories Excellent, Good, and Poor, while its descriptions define Easy, fair, and difficult. It does not explain how these terms correspond. In general, a consistent scoring rubric helps ensure that an outcome is applied the same way across participants and assessors. The registry record does not report assessor training, repeatability, or procedures for resolving uncertain ratings. This is relevant to interpretation because a surgeon’s rating may involve judgment rather than a purely mechanical measurement.
What does an estimate and its confidence interval communicate?
In general, an effect estimate summarizes the observed contrast between groups according to a defined statistical method. A confidence interval expresses the uncertainty around that estimate under the method’s assumptions. A narrow interval indicates greater precision than a wide interval, but neither the estimate nor the interval alone establishes clinical importance. Both must be interpreted in light of the outcome scale, the study design, and possible bias. The registry record does not report a primary-outcome estimate or confidence interval, so neither the apparent magnitude nor the precision of a contrast can be assessed.
The study also lists recovery time from neuromuscular blockade as a secondary outcome. In general, time outcomes require clear definitions of when timing begins and ends, and a description of how observations that are incomplete or censored are handled. The registry record does not report those definitions or methods. It gives no recovery-time summaries or comparison, so the secondary outcome cannot be interpreted statistically from the record.
Why do analysis populations and missing data matter?
In general, an analysis population specifies which randomized participants contribute to a particular estimate. An analysis that retains participants according to assigned group addresses a different question from one limited to participants who followed a protocol or had complete measurements. Missing observations can affect a comparison if missingness is related to treatment, outcome, or participant characteristics. Statistical methods can describe or address missingness, but their appropriateness depends on why data are missing and how much information is absent. The analysis population, missing-data counts, and handling procedures are not reported in the registry record.
The record says that two analyses are associated with two outcome measures, but does not give the statistical plan or identify methods for either outcome. In general, a prespecified plan helps clarify the primary comparison, outcome handling, and decision rules before results are known. It also helps readers distinguish planned analyses from exploratory ones. The registry record does not report whether a plan was prespecified, whether interim analyses occurred, or how any deviations were handled. None of these details should be inferred from the randomized design or the completion status.
Finally, a sample-size calculation is a planning exercise, not a description of observed evidence. In general, such calculations rely on assumptions about the effect of interest, variability or event frequency, significance level, allocation, and analysis method. An illustration based on an observed effect is not the same as the trial’s original design justification, and it is not observed power. The registry record does not report a sample-size justification or a trial-specific statistical plan. No planning calculation can replace the missing outcome counts and comparative estimates.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome, laryngoscopic score, and a secondary outcome, recovery time from neuromuscular blockade. It also indicates two outcome measures and two analyses. The record does not describe a multiplicity strategy, such as how interpretation would account for considering more than one outcome or more than one comparison. In general, when several statistical questions are examined, the chance of at least one apparently notable finding can increase unless the analysis plan addresses that issue. The registry record does not state whether such an adjustment or hierarchy was planned.
The primary endpoint has several named categories, but its category counts and analysis method are not reported. The record also does not explain the correspondence between its category labels and verbal definitions. Without those details, readers cannot tell whether categories were compared separately, combined, or modeled in an ordered fashion. No p-value or confidence interval for the endpoint is reported, so there is no posted inferential result to interpret.
Missing-data information is not reported in the registry record. The record does not state whether all enrolled participants contributed primary or secondary outcome data, whether any measurements were unavailable, or how missing observations were handled. It also does not identify the analysis population for either outcome. These omissions matter because the set of participants included and the handling of incomplete measurements can influence the interpretation of a group comparison.
The record does not report interim analyses, stopping rules, or a detailed statistical plan. Their absence from the record should not be read as evidence that a particular procedure was or was not used. The appropriate conclusion is that these aspects are not reported in the registry record, leaving the analysis choices and their potential implications unclear.
11. 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 |
|---|---|---|---|
| Rocuronium 0.45 - Neostigmine | 0 | 22 | 0.0% |
| Rocuronium 0.9 - Sugammadex | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rocuronium 0.45 - Neostigmine | 0 of 22 |
| Rocuronium 0.9 - Sugammadex | 0 of 22 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Rocuronium 0.45 - Neostigmine | 0 of 22 |
| Rocuronium 0.9 - Sugammadex | 0 of 22 |
The registry lists 22 participants at risk in each arm. For the rocuronium 0.45 - neostigmine arm, it records zero serious adverse events, zero other adverse events, and zero deaths. The same counts are recorded for the rocuronium 0.9 - sugammadex arm. These are the safety counts available in the registry record.
A count of zero means that no events in the listed category were recorded for that arm in the registry results. It does not show that an event was impossible or that the regimens have identical safety. In general, rare events may not appear in a study of limited size, and safety reporting depends on how events are defined, monitored, and submitted. The registry record does not report event definitions, collection procedures, observation duration, or further event details.
The counts should not be converted into claims about comparative safety without a defined analysis and appropriate uncertainty estimates. The record does not provide a safety comparison, confidence interval, or assessment of differences between groups. The listed zeros therefore describe reported events only; they do not establish the absence of all adverse effects.
12. What the Result Does, and Does Not, Mean
This record establishes that a completed randomized, single-masked, parallel-group study was registered to compare two regimens in laryngeal microsurgery. It identifies surgeon-rated laryngoscopic score as the primary outcome and recovery time from neuromuscular blockade as a secondary outcome. It also records the arm descriptions, enrollment, study status, and safety counts. Those details clarify the intended comparison and the measurements the study set out to examine.
The record does not report the primary outcome category counts or a comparative estimate. It also does not report recovery-time results. Therefore, the record does not show which regimen had better-rated laryngoscopic conditions, whether recovery time differed, or how precise either comparison was. The study’s stated aim must not be confused with evidence that either outcome favored one arm.
The absence of a reported estimate also does not demonstrate that the regimens were equivalent. Establishing similarity or ruling out a meaningful difference requires an appropriate analysis and enough precision to exclude differences of interest. No such analysis or uncertainty interval is reported in the registry record.
The zero adverse-event counts are a limited description of the safety data recorded for the study. They do not prove that no harm could occur, and they do not provide a basis for comparing overall safety. More complete interpretation would require event definitions, monitoring details, and an analysis appropriate to the available data.
In short, the registry record supports a description of study design and recorded safety counts, but not a conclusion about comparative efficacy, recovery, or safety. Further outcome results and analysis details would be needed to judge the size, precision, and robustness of any treatment contrast.
13. Why This Trial Matters Statistically
This study raises statistical questions that are important when a clinical endpoint is a surgeon’s categorical assessment. The score is intended to summarize laryngoscopic conditions, but its interpretation depends on consistent category definitions and a transparent account of how ratings are distributed. The record names Excellent, Good, and Poor while describing Easy, fair, and difficult. Resolving that wording and reporting the category counts would be necessary to understand the measured outcome and its comparison.
The study also compares regimens that differ in the rocuronium dose named in the arm descriptions and in the reversal agent identified by the arm names and summary. The detailed arm wording is not fully clear about which reversal injection is administered. In general, precise descriptions of the treatment contrast are important for interpreting what a group difference would mean. The registry record leaves that practical detail uncertain.
Statistical importance also comes from distinguishing an intention to compare from a reported result. The registry states that surgical condition and recovery time were the intended subjects of comparison, yet it does not report outcome values or estimates. A completed status and a registered analysis count do not reveal the direction, magnitude, or precision of an outcome difference.
Finally, the safety counts are zero in both arms, but those counts do not resolve questions about uncommon events or comparative risk. The record gives a useful account of what was recorded, while its missing outcome and methods details limit further inference. This illustrates why clinical interpretation depends not only on study design, but also on complete outcome reporting and clear statistical methods.
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.
Outcome reporting is the central limitation for interpreting this study from the registry record. The primary laryngoscopic-score categories are described, but no category counts, group comparison, effect estimate, or uncertainty interval is reported. Recovery time from neuromuscular blockade is listed as a secondary outcome, but its results are not reported in the registry record either. Without these results, no treatment contrast can be characterized.
The endpoint description has an internal terminology ambiguity: the categories are labeled Excellent, Good, and Poor, while the definitions use Easy, fair, and difficult. The record does not explain the mapping between these terms. It also does not report assessor procedures or reliability information for the surgeon rating. These omissions make it harder to assess how consistently the primary outcome was measured.
The regimen descriptions contain another ambiguity. The summary and arm names identify neostigmine in one arm and sugammadex in the other, but the detailed descriptions refer to an injection of neostigmine or sugammadex without consistently specifying which is administered in each group. The exact treatment contrast is therefore not fully clear from the record’s wording.
Other details needed to evaluate the analysis are not reported in the registry record: the allocation process, the identity of the masked party, participant characteristics, eligibility criteria, analysis populations, missing-data handling, statistical methods, and sample-size justification. The record also does not report a detailed safety-monitoring approach. These limitations do not show that procedures were absent; they mean that the registry record does not describe them.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery. — NCT02330172.
- Registry record last updated 2017-04-17; status last verified 2015-07.
- Results first posted 2017-04-17.
- 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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18. Record Summary
The registry record describes a completed randomized, single-masked, parallel-group study sponsored by Seoul National University Hospital, with enrollment of 44. The study compared rocuronium 0.45 mg/kg with neostigmine against rocuronium 0.9 mg/kg with sugammadex for laryngeal microsurgery. It lists laryngoscopic score as the primary outcome and recovery time from neuromuscular blockade as a secondary outcome.
The primary outcome is a surgeon rating at the beginning of surgery, with category labels and verbal descriptions recorded. The registry does not report the category counts, recovery-time results, or comparative estimates. It lists zero serious adverse events, zero other adverse events, and zero deaths in each arm, with 22 participants at risk per arm.
Important analysis and implementation details, including the statistical methods, analysis populations, missing-data handling, and masking target, are not reported in the registry record. The detailed descriptions of the reversal injection are also ambiguous. The record therefore permits description of the registered design and safety counts, but not a conclusion about comparative outcome results.