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Published on: September 24, 2020
Remimazolam versus Sevoflurane for Paediatric Circumcision: A Randomised Controlled Trial Evaluating Emergence
Yi Zhang1, Shuang Guo1, Linyun Wang2
1Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing, People's Republic of China.
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.
Insights
Remimazolam monotherapy significantly reduced emergence delirium in children by 67% compared to sevoflurane anesthesia. This volatile-free alternative offers faster recovery and a better family experience, though careful fluid management is advised due to potential hypotension.
Area of Science:
- Anesthesiology
- Pediatric Anesthesia
- Pharmacology
Background:
- Emergence delirium affects up to 40% of pediatric sevoflurane anesthetics.
- Remimazolam, an ultra-short-acting benzodiazepine, offers rapid, predictable recovery via esterase metabolism.
- Investigating remimazolam as a volatile-free alternative to reduce emergence delirium in children.
Purpose of the Study:
- To evaluate remimazolam monotherapy as a volatile-free anesthetic alternative.
- To compare the incidence of emergence delirium between remimazolam and sevoflurane.
- To assess induction and emergence times, and patient/guardian experience.
Main Methods:
- Prospective, randomized, assessor-blinded trial in 100 children (3-12 years) undergoing circumcision.
- Randomized 1:1 to remimazolam or sevoflurane anesthesia, both with penile nerve block.
- Co-primary outcomes: induction and emergence times; Key secondary outcome: emergence delirium (PAED score ≥12).
Main Results:
- Remimazolam group had significantly lower emergence delirium (12% vs. 36%, P=0.009) and shorter PACU stay (33.4 vs. 40.7 min, P<0.001).
- Emergence was faster with remimazolam (10.7 vs. 13.5 min, P<0.001), while induction was slower (80.8 vs. 52.3 s, P<0.001).
- Transient hypotension occurred more in the remimazolam group (12% vs. 2%, P=0.11), but was fluid-responsive. Guardian anxiety was threefold reduced.
Conclusions:
- Remimazolam monotherapy effectively reduces emergence delirium by 67% compared to sevoflurane.
- It provides faster recovery and an improved family experience in pediatric anesthesia.
- Further multicenter trials are recommended to confirm safety and broader applicability, with attention to preoperative fluid management.
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