Evidence item

In this single-center, randomized, group-sequential non-inferiority trial, low-risk adults undergoing elective thyroid surgery were assigned to intubation with face-mask ventilation using rocuronium 0.6 mg/kg or without face-mask ventilation using rocuronium 1.2 mg/kg. The primary desaturation threshold was SpO2 ≤95%, with a 2% non-inferiority margin. The trial stopped at an interim analysis with 288 participants (144 per group) in the absence of events rather than by a stopping rule. No patient desaturated, but the 95% confidence interval for the risk difference was −2.6% to 2.6%, so formal non-inferiority was not established. Prespecified post-intubation gastric antral cross-sectional area did not differ (median 3.7 cm² in both groups, P=0.99); post hoc gastric-insufflation analyses found events only in the ventilation group: 8/144 (5.6%) versus 0/144 by qualitative sign and 9/144 (6.2%) versus 0/144 by the CSA threshold.