Noninferiority is a question about an allowed difference, not proof that two anesthetic strategies have the same effect.
Study findings
The randomized double-blind study analyzed 162 older patients undergoing video-assisted thoracic surgery. Postoperative delirium occurred in 20.73% with remimazolam and 18.75% with dexmedetomidine; emergence agitation occurred in 10.98% and 8.75%. The authors reported noninferiority. Several secondary hemodynamic and recovery measures favored remimazolam, while the dexmedetomidine group had a better first-day insomnia score.
What limits the conclusion
The report describes its sample-size margin using relative risk and describes the final assessment using an incidence difference. That presentation requires care when interpreting the noninferiority claim. Fourteen randomized patients were excluded from final analysis. Secondary findings were exploratory, and the population excluded important preoperative cognitive and cardiovascular conditions.
Implications for case review
For an expert report, retain the actual event proportions and study design rather than replacing them with an unqualified statement that the drugs are equivalent. Examine the margin, confidence interval and analysis population before relying on a noninferiority label. The trial does not show that either strategy prevents all delirium, and its observed association between hypotension and delirium cannot establish a causal mechanism in an individual patient.
Source and related reading
Source: PMC12577633, supplied full-text paper. Findings are paraphrased; forensic implications are an interpretation.
Related: Benzodiazepine Use Was One of Several Delirium Predictors After Aortic Repair.
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