Trial reportDrug design, development and therapy2026
Remimazolam ED95 for Preoperative Sedation in Children with Obstructive Sleep Apnea, with Obesity or a Reference-Range BMI: A Biased-Coin Dose-Finding Study.
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.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Obesity may alter total-body-weight dosing of remimazolam, whereas obstructive sleep apnea narrows the respiratory safety margin. We estimated the ED95 for protocol-defined preoperative sedation in children with obesity or a reference-range body mass index (BMI). Methods: In this prospective, single-center sequential dose-finding study, 80 children aged 3-17 years with a clinical OSA diagnosis undergoing adenoidectomy and/or tonsillectomy entered study-defined obesity (BMI-for-age >95th percentile) or reference-BMI (25th-84th percentile) groups (40 each). Independent biased-coin sequences used total-body-weight doses, starting at 0.20 mg/kg with 0.05 mg/kg steps. The response was a Ramsay Sedation Scale (RSS) score ≥4 at 3 minutes after completion of a 1-minute intravenous bolus. Isotonic regression and 2000 bootstrap resamples yielded ED95 estimates and bias-corrected percentile 95% confidence intervals (CIs). Results: Responses occurred in 35/40 (87.5%) participants in the obesity group and 34/40 (85.0%) in the reference-BMI group. ED95 estimates were 0.38 mg/kg (95% CI, 0.32-0.39) and 0.44 mg/kg (95% CI, 0.39-0.44), respectively. The difference was -0.05 mg/kg (95% CI, -0.13 to 0.05). During 15-minute observation, one child per group developed hypoxemia (SpO2 93%) that resolved after a jaw-thrust maneuver. One reference-BMI participant developed bradycardia (50 beats/min), which responded to atropine. No child had a ≥30% decrease in mean arterial pressure. Conclusion: The protocol-specific ED95 values of a 1-min remimazolam bolus for RSS ≥4 at 3 min were 0.38 mg/kg in children with obesity and 0.44 mg/kg in children with a reference-range BMI.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.