2026-10-14T04:20:04Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33995369 2026-09-25T13:40:50Z category_7 category_12 category_15 category_19 category_64 category_122 portal_87 item_type_3 month_year_09_2026

Bispectral index during remimazolam versus propofol sedation at matched depths: a randomized, double-blind crossover trial in healthy volunteers Senlin Cai (25110230) Xiaofen Hu (264333) Yuqian Wei (10076524) Ting Zheng (608653) Shengyuan Xie (25110233) Huifen Lin (1435102) Xiaobin Pan (9403710) Medicine Cell Biology Neuroscience Pharmacology Cancer Mental Health Chinese Clinical Trial Registry ChiCTR2500112548 Remimazolam propofol bispectral index procedural sedation cognitive recovery crossover trial <p>The bispectral index (BIS) was derived primarily from propofol data, and whether its thresholds apply to remimazolam is uncertain. We compared BIS between the two agents at matched sedation depths and examined early cognitive recovery.</p> <p>In this prospective, randomized, double-blind, two-period crossover trial, 16 healthy volunteers (American Society of Anesthesiologists physical status I) received remimazolam and propofol in random order, ≥ 7 days apart. Each agent was titrated to moderate (Modified Observer’s Assessment of Alertness/Sedation [MOAA/S] 3) and deep (MOAA/S 1) sedation. The confirmatory outcome was mean BIS at deep sedation. All other outcomes were exploratory: BIS at moderate sedation and at loss of the eyelash reflex, emergence time, and cognitive recovery at 30 and 120 min.</p> <p>At deep sedation, mean BIS was higher with remimazolam (57.6 ± 7.5) than with propofol (46.5 ± 7.9; adjusted difference 11.1 units; 95% CI, 7.3 to 14.8; <i>p</i> < 0.001). In exploratory analyses, BIS was also higher at moderate sedation and at loss of the eyelash reflex (both <i>p</i> < 0.001), and emergence time did not differ (<i>p</i> = 0.606). At 30 min, processing speedand  executive function recovered faster after remimazolam (p = 0.012 and p < 0.001), whereas verbal memory did not differ between agents. All domains converged by 120 min. Adverse events were uncommon, and the trial was not powered to compare them.</p> <p>At clinically matched sedation depths, remimazolam produced higher BIS values than propofol. Spectral data were not recorded, so the basis of this offset is undetermined, and the cognitive findings were exploratory. Whether this offset warrants agent-specific reference values requires validation in clinical populations.</p> <p></p><p>Remimazolam produced higher BIS values than propofol at all three clinically matched sedation depths in healthy young volunteers.</p><p>Because depth was matched by clinical endpoint, these higher readings do not indicate lighter sedation as conventionally defined.</p><p>Whether this offset warrants agent-specific reference values requires validation in clinical populations before implementation.</p><p></p> <p>Remimazolam produced higher BIS values than propofol at all three clinically matched sedation depths in healthy young volunteers.</p> <p>Because depth was matched by clinical endpoint, these higher readings do not indicate lighter sedation as conventionally defined.</p> <p>Whether this offset warrants agent-specific reference values requires validation in clinical populations before implementation.</p> 2026-09-25T13:40:50Z Dataset Dataset 10.6084/m9.figshare.33995369.v1 https://figshare.com/articles/dataset/Bispectral_index_during_remimazolam_versus_propofol_sedation_at_matched_depths_a_randomized_double-blind_crossover_trial_in_healthy_volunteers/33995369 CC BY 4.0