Methodological Caution in Interpreting Efficacy and Safety of Ciprofol-Alfentanil Sedation for Pediatric Bronchoscopy [Letter]

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Yang et al's study 1 adds timely prospective data to pediatric bronchoscopy anesthesia, suggesting that ciprofol combined with alfentanil, particularly 10 μg/kg, may improve cough suppression, operator satisfaction, and the need for rescue ciprofol during fiberoptic bronchoscopy.Their randomized controlled trial evaluated three anesthetic regimens: ciprofol combined with 5 μg/kg alfentanil group (Group A), ciprofol combined with 10 μg/kg alfentanil group (Group B) and ciprofol-only group (Group C).In a field where procedural conditions and airway safety must be balanced minute by minute, that contribution is valuable.Even so, two methodological issues deserve closer discussion.The first concerns the claimed intention-to-treat analysis.The Methods section states that if a child required endotracheal intubation or the surgical approach was altered, that patient would be excluded and "will not be included in the final intention-to-treat analysis".The CONSORT flowchart then shows exactly such post-randomization exclusions: one child in group A required tracheal intubation and one child in group C underwent a merged surgical procedure, leaving 97 analyzed after 99 were randomized.This is not a minor wording issue.Intention-to-treat (ITT) preserves randomized allocation as far as possible, whereas excluding participants after randomization moves the analysis toward a modified ITT or per-protocol framework and weakens protection against bias.2,3 More importantly, these omitted cases are clinically informative.A need for intubation is not background noise.It is a treatment failure or safety signal.Removing such events can make an anesthetic strategy appear both more effective and safer than it truly is.The second issue involves the safety conclusion.The article states that 10 μg/kg alfentanil did not increase adverse reactions.Yet the study shows intraoperative respiratory depression in 7 of 33 children in the ciprofol combined with 10 μg/kg alfentanil group (Group B), compared with 4 of 32 in the ciprofol combined with 5 μg/kg alfentanil group (Group A) and 5 of 32 in the ciprofol-only group (Group C), or 21.2% versus 12.5% and 15.6%, respectively.The absence of statistical significance, with P = 0.631, should not be read as evidence of equivalent safety.The sample size was calculated from cough scores, not respiratory events.Under those circumstances, the study may detect differences in procedural efficacy but remains underpowered for harm.Contemporary statistical guidance has warned against treating nonsignificant findings as proof of no difference.4 In pediatric sedation, respiratory compromise may also be underestimated when surveillance relies mainly on oxygen saturation during supplemental oxygen.In a 2025 prospective study of 101 sedated children, capnography identified 93 episodes of respiratory depression, whereas pulse oximetry alone identified only 53, with a median 35-second detection advantage.Capnography detected respiratory depression through early physiological changes, including rising ETCO2 during hypoventilation and loss of the capnographic waveform during apnea, before oxygen desaturation became evident on pulse oximetry.5 Reframing the analysis as a modified intention-to-treat (mITT) analysis, reporting all randomized patients in the main results tables, and presenting confidence intervals for between-group differences in adverse-event rates would further strengthen the manuscript.Larger multicenter trials adequately powered to evaluate respiratory safety outcomes remain Therapy 2026:20 618772 1 Drug Design, Development and

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