Remimazolam versus Sevoflurane for Paediatric Circumcision: A Randomised Controlled Trial Evaluating Emergence Delirium

Yi Zhang,1 Shuang Guo,1 Linyun Wang,2 Qingjun Zeng,1 Haishan Cui,1 Yunbo Mo3 1Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing, People’s Republic of China; 2Nursing Department, Maternal and Child Health Hospital of Wanzhou District, Chongqing, People’s Republic of China; 3Department of Pediatrics, Maternal and Child Health Hospital of Wanzhou District, Chongqing, People’s Republic of ChinaCorrespondence: Yunbo Mo, Department of Pediatrics, Maternal and Child Health Hospital of Wanzhou District, No. 8 Wanquan Road, Wanzhou District, Chongqing, 404000, People’s Republic of China, Email [email protected]: 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.Plain Language Summary: Emergence delirium affects up to 40% of children after sevoflurane anaesthesia, causing distress to patients and families.Remimazolam monotherapy reduced emergence delirium from 36% to 12% versus sevoflurane (relative risk 0.33; NNT 4.2).Remimazolam provided faster emergence (21% reduction) and shorter PACU stay (18% reduction).Transient hypotension occurred more frequently with remimazolam (12% vs 2%) but responded to fluid therapy.These findings support remimazolam as a volatile-free alternative for paediatric ambulatory anaesthesia.Keywords: anaesthesia, paediatric, anaesthetics i.v., remimazolam, anaesthetics volatile, sevoflurane, complications, emergence delirium, randomised controlled trial