Trial reportDrug design, development and therapy2026
Remimazolam versus Sevoflurane for Paediatric Circumcision: A Randomised Controlled Trial Evaluating Emergence Delirium.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
Background: Emergence delirium complicates up to 40% of paediatric sevoflurane anaesthetics. Remimazolam is an ultra-short-acting benzodiazepine with organ-independent esterase metabolism, offering rapid and predictable recovery. We tested whether remimazolam monotherapy could serve as a volatile-free alternative to reduce emergence delirium. Methods: We conducted a prospective, randomised, assessor-blinded trial (ChiCTR2500095974). One hundred children aged 3-12 years (ASA I-II) undergoing circumcision were randomised 1:1 to remimazolam (0.3 mg kg Results: Emergence was faster with remimazolam (10.7 [SD 3.9] vs 13.5 [3.7] min; P<0.001). Induction was slower (80.8 [9.8] vs 52.3 [8.2] s; P<0.001) due to the slow-injection protocol. Emergence delirium occurred in 6/50 (12%) remimazolam patients versus 18/50 (36%) sevoflurane patients (relative risk 0.33; 95% CI 0.14-0.77; P=0.009; NNT 4.2). PACU stay was shorter (33.4 [8.5] vs 40.7 [10.9] min; P<0.001). Guardian anxiety reduction was threefold greater with remimazolam. Hypotension occurred in 6/50 (12%) remimazolam versus 1/50 (2%) sevoflurane patients (P=0.11); all cases were fluid-responsive. Conclusion: Remimazolam monotherapy reduced emergence delirium by 67% compared with sevoflurane, yielding faster recovery and improved family experience. However, a trend towards transient hypotension warrants appropriate preoperative fluid management. Larger multicentre trials are needed to confirm safety and broader applicability.
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