Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial (NCT05328973), a na phase 2 study. The primary outcome is To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo.

2. Clinical Question

3. Trial Design

The registry identifies a prospective, controlled trial of aromatherapy versus placebo during Port-a-Cath placement surgery under monitored anesthesia care. It describes the objective as comparing time to readiness for discharge from the post-anesthesia care unit (PACU). The listed intervention is ELEQUIL, described as a lavender-peppermint Aromatab patch. The comparator is placebo.

The record also contains conflicting design information. Its title and brief summary call the study randomized, but the structured allocation field is NA and the model is listed as single group. The record itself flags that the comparison is not a randomized comparison and that the arms are not a like-for-like control comparison. Consequently, the record does not establish from its structured design information how participants were assigned or whether the two arms can be interpreted as randomized groups. Details resolving this discrepancy are not reported in the registry record.

The registry reports enrollment of 70 and lists the study status as completed. Its recorded start date is 2022-05-18 and its primary completion date is 2024-01-16. The sponsor is M.D. Anderson Cancer Center, and the condition is Cancer Pain. The record lists phase 2.

Secondary outcomes include preoperative anxiety measured with HADS; intraoperative midazolam and opioid use; intraoperative anti-emetic use; postoperative nausea or vomiting and its rate and intensity in PACU; anti-emetic use in PACU; and opioid use in PACU. The record lists 11 outcome measures but no analyses. It does not report an analysis population, participant flow, or results for the primary endpoint.

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

Reasons for not completing this period:

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 To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo, measured over from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average.

The primary endpoint is time to readiness for discharge from PACU, measured in minutes. The description defines the interval as beginning at PACU arrival and ending when the patient is ready for PACU discharge. The registry timeframe also describes this interval as 1.5 hrs in average. That wording is a timeframe description, not a reported comparison between the aromatherapy and placebo groups.

Readiness for discharge is a time-based measure of recovery in the immediate period after surgery and anesthesia. As a general statistical point, a continuous time measure can retain information about variation in duration, rather than reducing each patient's experience to a yes-or-no outcome. Comparing group averages can describe whether the recorded mean time differs, but interpretation depends on having group-level estimates, uncertainty measures, and a clearly specified analysis population. The registry identifies mean and standard deviation as the measure and dispersion, respectively, but does not post the endpoint values or a treatment-effect estimate.

The endpoint is relevant to the stated trial objective because it focuses on the time from arrival in recovery to readiness for discharge. It does not, by itself, describe all aspects of recovery or establish why any difference might occur. The record does not report how readiness was judged, who made that assessment, whether the assessment was blinded, or how incomplete endpoint observations were handled. These details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean represent?

The registry identifies the primary outcome as a continuous measure and names the mean as its summary measure, with standard deviation as the dispersion measure. A mean is an average that describes the center of a set of observations. A standard deviation describes how spread out observations are around that mean. These summaries answer different questions: the mean concerns the typical level on the measured scale, while the standard deviation concerns variation among observations.

As a general statistical point, means and standard deviations can be useful for communicating a continuous outcome, but they do not show the full shape of the data. A few unusually long or short times can influence a mean. The record does not report the observed distributions, group means, standard deviations, or an analysis of the primary endpoint, so no specific conclusion about the shape or variability of recovery times can be drawn.

What would a group comparison require?

A comparison of the primary outcome would ordinarily summarize the endpoint for each group and estimate a between-group contrast, with an uncertainty measure such as a confidence interval. The exact contrast and model depend on the analysis plan and data. The registry does not report the primary result, the statistical model, a confidence interval, or a p-value. It also does not report a statistical analysis plan. It would be inappropriate to infer the analysis from the endpoint description alone.

As a general statistical point, a confidence interval communicates the precision of an estimate under the assumptions of the method used. Wider intervals indicate less precision than narrower intervals, but precision is not the same as validity. A precise estimate can still be misleading if groups are not comparable, the endpoint is measured differently between groups, or important observations are missing. In this trial record, uncertainty about the design fields is especially relevant because the structured entry does not confirm random allocation.

Why does allocation matter?

Random allocation is a method for assigning participants to groups by chance. In general, it can reduce systematic differences in measured and unmeasured characteristics at assignment, supporting interpretation of a group contrast. The title and brief summary describe randomization, but the structured allocation field is NA and the model is single group. The registry's own warning says the arms are not a like-for-like control comparison. The record does not explain this mismatch, so the intended randomized design cannot be verified from the posted information.

As a general statistical point, when groups differ for reasons other than the intervention, an observed outcome contrast may reflect those differences as well as the intervention. Adjustment can sometimes address measured differences, but it cannot automatically correct unmeasured confounding, and the registry does not report adjusted analyses. No particular adjustment method should be assumed.

How should sample-size illustrations be understood?

Any sample-size material associated with this record is described as a planning illustration based on the observed effect, rather than as the trial's own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For non-time-to-event outcomes, the planning quantity is participants per arm for 80% power or another stated target; time-to-event quantities are described as total events.

As a general statistical point, a planning calculation asks how much information a future study might need under specified assumptions. It does not tell how likely the completed study was to detect an effect, and it is not observed power. Here, the primary observed effect is not reported in the registry record, and no numerical planning outputs are included in the record details. The illustrations should therefore not be treated as evidence about the outcome or as confirmation that the trial was adequately powered.

What can the adverse-event counts tell us?

The registry lists serious adverse events and other adverse events by arm, along with the number at risk. These are descriptive counts. As a general statistical point, counts alone do not convey uncertainty about a difference in event risk, and rare events can be difficult to compare reliably. The record does not provide a statistical safety comparison, event definitions, or details on how events were collected. The counts should be read as registry-reported observations, not as proof of equivalence or of a causal relationship.

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("Elequis Aromatab (Lavander/Pepermint)", "Placebo")
n   <- c(35, 34)
m   <- c(82.057, 89.382)
sp  <- c(15.376, 21.25)
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  Elequis Aromatab (Lavander/Pepermint)  35  82.057  15.376  76.775  87.339
CARM  Placebo  34  89.382  21.250  81.968  96.796

11. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome and secondary outcomes covering preoperative anxiety, use of medications during surgery and PACU recovery, and postoperative nausea or vomiting. It identifies 11 outcome measures and 0 analyses. The record does not specify which secondary outcomes were formally tested, how many comparisons were planned, or whether any adjustment for multiple testing was used. Those details are not reported in the registry record.

As a general statistical point, testing many outcomes can increase the chance that at least one result appears notable by chance, even when there is no true effect on any outcome. A prespecified hierarchy or a multiplicity adjustment can help control that risk, but neither should be assumed without a reported plan. The absence of posted analyses also means there are no outcome-specific estimates or p-values to evaluate.

The registry does not report missing-data rates, reasons for missingness, imputation methods, or sensitivity analyses. It also does not identify an intention-to-treat, per-protocol, or other analysis population. As a general statistical point, missing observations can affect both the estimated outcome and its precision; the direction and magnitude of that effect depend on why data are missing and on the analysis used. Without these details, it is not possible to assess how missingness may have influenced the primary or secondary outcomes.

Participant flow, protocol deviations, and the relation between enrollment and the population used for analysis are not reported in the registry record. These omissions matter for interpreting any trial result, but no result is posted for this comparison. The completion status and enrollment entry do not supply the missing analysis details.

12. 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 2% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event entry lists no serious adverse events in either arm. It lists 1 other adverse event among 35 at risk in the Elequis Aromatab (Lavander/Pepermint) arm and 3 among 34 at risk in the placebo arm. These are the registry's recorded counts and denominators; they should be read descriptively.

As a general statistical point, event counts do not by themselves establish whether one group had a higher or lower underlying risk. A formal comparison would require an appropriate estimate and uncertainty measure, along with adequate information about how events were defined, collected, and attributed. The registry does not report such a safety analysis, the definitions of serious and other events, or details about duration of safety follow-up. It lists no top serious-event terms.

The lack of reported serious events in these entries does not establish that serious events cannot occur. The counts also do not show whether the groups were comparable, particularly given the record's conflicting design information. They should not be interpreted as evidence of equivalence or as an estimate of the aromatherapy's causal safety effect.

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

The registry record describes a clinical question about aromatherapy during Port-a-Cath placement under monitored anesthesia care: whether time from PACU arrival to readiness for discharge differs from the time under placebo. It identifies a lavender-peppermint Aromatab patch as the intervention and mean time in minutes as the primary outcome. The record also lists secondary outcomes relating to anxiety, medication use, and postoperative nausea or vomiting.

What the record does not provide is the result needed to answer that question. There are no posted group values for the primary endpoint, no estimated between-group contrast, and no confidence interval or p-value. The secondary outcome results are also not reported. Accordingly, the record does not show the size or precision of any observed difference, and it cannot support a conclusion about whether the groups differed on the stated outcomes.

The stated study status is completed, but that status does not substitute for results. The record reports enrollment of 70, but does not say how many participants contributed to each analysis or how missing observations were handled. In addition, the title and brief summary describe randomization while the structured design fields say allocation NA and single group, and the record flags the arms as not like-for-like. The available information therefore leaves the intended comparison uncertain.

As a general statistical point, a treatment effect is not established merely because a study has a comparator, an outcome, or a completed status. Interpretation depends on the observed data, the precision of the estimate, the study design, and the analysis. These elements are not fully. The adverse-event counts provide limited descriptive information, but do not answer the primary question or establish comparative safety.

The appropriate reading is therefore narrow: this registry entry describes the trial question, the planned endpoint, the listed arms, and selected adverse-event counts, while leaving the comparative results unavailable. It neither demonstrates benefit nor demonstrates lack of benefit. No clinical decision should be inferred from an absent outcome analysis.

14. Why This Trial Matters Statistically

This trial raises a practical statistical question about how a continuous recovery-time endpoint is defined, summarized, and compared. Readiness for discharge is recorded as a duration from PACU arrival to discharge readiness. Such an endpoint can be clinically interpretable as elapsed time, but useful statistical interpretation requires the group estimates, variability, and uncertainty—not just the endpoint label. Those primary results are not reported in the registry record.

The record also illustrates why registry design fields deserve careful reading. The title and summary describe a randomized comparison, but the structured entries identify allocation as NA and the model as single group, and the record explicitly cautions against treating the arms as like-for-like. This matters because the meaning of a group difference depends in part on how groups were formed. A clear, consistent design description is necessary to judge whether an observed contrast can be interpreted as an intervention effect.

The several listed secondary outcomes create another general statistical consideration: a study can measure many related outcomes, and readers need to know which comparisons were prespecified and how multiplicity was handled. The record lists 11 outcomes and 0 analyses, without a reported statistical plan or results. Consequently, it is not possible to assess whether outcome selection or multiple testing affected the interpretation.

Finally, the entry distinguishes between an intended study question and an interpretable result. Completion status, an enrollment entry, and adverse-event counts are not substitutes for a primary estimate and its precision. For statistical readers, the main lesson is that transparent reporting of design, analysis populations, missing data, and outcome estimates is needed to move from a trial description to a credible comparison.

15. Limitations

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

The most consequential limitation of the registry information is that the primary outcome results are not reported. There are no group means, standard deviations, effect estimates, confidence intervals, or p-values for time to readiness for discharge. Without these, the magnitude and precision of the comparison cannot be assessed. Secondary outcome results and analyses are also absent.

The record contains conflicting design descriptions: the title and brief summary call the study randomized, while structured fields list allocation as NA and a single-group model. The record further says the arms are not a like-for-like control comparison. It does not explain the discrepancy or provide assignment procedures that would resolve it. This limits any causal interpretation of a group contrast.

Other trial details needed to assess the analysis are not reported in the registry record. These include the analysis population, participant flow, endpoint missingness, handling of missing data, the statistical model, prespecified hypotheses, multiplicity procedures, and the basis for the sample-size design. The registry describes sample-size calculations as planning illustrations based on an observed effect, not as the trial's own design, but no numerical planning outputs are included in the record details.

The primary endpoint's operational details are also limited. The record defines the start and end of the interval and names mean and standard deviation, but does not report how readiness was determined, who assessed it, or whether assessment was blinded. The safety entry supplies counts but not event definitions, ascertainment procedures, or a comparative analysis. These limitations restrict what can be learned from the posted registry information, independent of the trial's stated completed status.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial — NCT05328973.
• Registry record last updated 2024-12-02; status last verified 2024-11.
• Results first posted 2024-12-02.
• 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.

19. Record Summary

The registry record identifies a phase 2 study sponsored by M.D. Anderson Cancer Center, with a listed condition of Cancer Pain. It reports enrollment of 70, a start date of 2022-05-18, a primary completion date of 2024-01-16, and completed status.

The stated objective is to compare mean time to readiness for PACU discharge after Port-a-Cath placement under monitored anesthesia care. The intervention is described as a lavender-peppermint Aromatab patch, with placebo as comparator. The title and summary describe randomization, but the structured record lists allocation as NA and the model as single group, and cautions that the arms are not a like-for-like comparison.

The registry lists 11 outcome measures and 0 analyses. It does not report the primary endpoint results or the statistical plan. Adverse-event entries list no serious adverse events and report other-event counts of 1 in the Aromatab arm and 3 in the placebo arm. These are descriptive entries, not a comparative safety analysis.