Drug design, development and therapy · 2026
Remimazolam versus Sevoflurane for Paediatric Circumcision: A Randomised Controlled Trial Evaluating Emergence Delirium.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Zhang Yi, Guo Shuang, Wang Linyun, Zeng Qingjun, Cui Haishan, Mo Yunbo
Аннотация
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- 1 induction; 0.75 mg kg- 1 h- 1 maintenance) or sevoflurane (8% induction; 1.5-2.5 MAC maintenance). All received penile nerve block. The co-primary outcomes were induction and emergence times. The key secondary outcome was emergence delirium (PAED score ≥12).
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.
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- 1 induction; 0.75 mg kg- 1 h- 1 maintenance) or sevoflurane (8% induction; 1.5-2.5 MAC maintenance). All received penile nerve block. The co-primary outcomes were induction and emergence times. The key secondary outcome was emergence delirium (PAED score ≥12).
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.